FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4368), H4525, H4526, H4527, H4528, H4529, H4530, H4531, H4532, H4533, H4534, H4535, H4536, H4537, H4538, H4539, H4540, H4541, H4542, H4549, H4550, H4551, H4552, H4553, H4554, H4555, H4556, H4557, H4559, H4560, H4561, H4562, H4563, H4564, H4565 [26SE]

Articles and editorials

Updated Covid Boosters Cut the Infection Risk From XBB.1.5 Subvariant by Nearly Half, CDC Finds, H545 [31JA]

Bills and resolutions

Abortion: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (see S. 95), S120 [26JA] (see H.R. 427), H249 [20JA]

——— nullify modifications made to risk evaluation and mitigation strategy for abortion pill mifepristone (see H.R. 383), H242 [17JA] (see H.R. 5850), H4909 [29SE]

——— preempt State restrictions on dispensing medication abortion (see H.R. 2573), H1717 [10AP]

——— preserve access to abortion medications (see S. 237), S229 [2FE] (see H.R. 767), H676 [2FE]

——— reaffirm authority to approve drugs for abortion care (see H. Res. 309), H1887 [19AP]

——— require more accurate reporting of abortion drug prescribing and related adverse events (see H.R. 2570), H1717 [10AP]

——— respect scientific judgement that mifepristone is safe and effective and ensure access to lifesaving, time-sensitive medication abortion care in U.S. is equitable and based on science (see S. Res. 510), S5997 [14DE]

Agriculture: provide authority to investigate animal feeding operations near produce farms where foodborne illness outbreaks occur to better determine root causes of such outbreaks (see S. 2782), S4440 [13SE] (see H.R. 4110), H2931 [14JN]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2131), S2222 [22JN] (see H.R. 4368), H3149 [27JN]

——— making appropriations (H.R. 4368), consideration (see H. Res. 723), H4496 [26SE]

Animals: address regulation of zootechnical animal food substances (see S. 1842), S2005 [7JN] (see H.R. 6687), H6740 [7DE]

——— reauthorize user fee programs relating to new animal drugs and generic new animal drugs (see S. 1844), S2005 [7JN] (see H.R. 1418), H1149 [7MR]

——— repeal guidance to require veterinary oversight for use of medically important antimicrobial animal drugs available as over-the-counter products (see H.R. 4012), H2807 [12JN]

Appropriations: limit funding (see H.R. 2295), H1637 [29MR]

——— limit funding for buildings and facilities (see H.R. 2296), H1637 [29MR]

——— limit funding for Innovation Account (see H.R. 2297), H1637 [29MR]

Children and youth: enhance safeguards relative to infant formula (see H.R. 5316), H4211 [29AU]

——— limit presence of toxic elements in, and otherwise regulate, infant and toddler food (see H.R. 6756, 6770), H6941 [13DE]

Contraceptives: allow women greater access to wider range of self-administered contraceptives (see H.R. 1512), H1248 [9MR]

——— encourage sponsors of oral contraceptive drugs to submit applications for approval of such drugs as over-the-counter (see H.R. 4626), H3574 [13JY]

——— preempt State bans on prescription, provision, or use of drug, biological product, or device for contraception if approved, licensed, cleared, or otherwise authorized for human use by FDA for contraception (see H.R. 3471), H2452 [18MY]

Cosmetics: ban certain substances in cosmetic products (see H.R. 3619), H2594 [24MY]

——— ban use of intentionally added per- and polyfluoroalkyl substances in cosmetics (see H.R. 6519), H6048 [30NO]

——— provide for greater transparency relative to fragrance and flavor ingredients in cosmetics (see H.R. 3621), H2595 [24MY]

——— provide grants to identify ingredients in salon products harmful to salon workers and women of color, promote green chemistry solutions, and require disclosure of ingredients on labels and company websites (see H.R. 3620), H2594 [24MY]

——— require cosmetic supply chains disclose ingredients, toxicity, and safety data to cosmetic companies needed to make safe cosmetics (see H.R. 3622), H2595 [24MY]

DEA: define currently accepted medical use with severe restrictions for controlled substances (see S. 689), S669 [7MR] (see H.R. 1393), H1148 [7MR]

Dept. of Agriculture: carry out activities to reduce food loss and waste (see S. 2889), S4654 [21SE] (see H.R. 5657), H4455 [21SE]

Dept. of HHS: allow expedited approval of generic prescription drugs and temporary importation of prescription drugs during noncompetitive drug markets and drug shortages (see S. 845), S825 [16MR]

——— conduct study on designation of biosimilar biological products as interchangeable (see S. 1522), S1602 [10MY]

——— establish program to develop antimicrobial innovations targeting most challenging pathogens and most threatening infections (see S. 1355), S1418 [27AP] (see H.R. 2940), H2083 [27AP]

——— evaluate process by which interchangeable biological products are approved to be used in pharmaceuticals (see H.R. 1790), H1437 [24MR]

——— mitigate drug shortages and provide incentives for manufacturing of active pharmaceutical ingredients, excipients, medical devices, pharmaceuticals, and personal protective equipment (see H.R. 2707), H1885 [19AP]

——— prohibit use or declaration of public health emergency with respect to abortion (see H.R. 384), H242 [17JA]

——— reauthorize comprehensive opioid recovery centers (see H.R. 1502), H1247 [9MR]

——— report on interoperability of medical devices (see H.R. 1557), H1279 [10MR]

——— support endemic fungal disease research, incentivize valley fever vaccine development, and discover new antifungal therapies and diagnostics to fight infections such as Valley Fever (see S. 3464), S5919 [12DE] (see H.R. 6731), H6859 [12DE]

——— update and clarify rule on substances generally recognized as safe and establish Office of Food Chemical Safety, Dietary Supplements, and Innovation within FDA (see S. 3387), S5712 [4DE]

Disabled: establish nonvisual accessibility standards for certain devices with digital interfaces (see H.R. 1328), H1049 [1MR]

Diseases and disorders: establish additional authorities regarding conduct of pediatric investigations of molecularly targeted drugs to treat cancer (see S. 2897), S4654 [21SE] (see H.R. 3433), H2425 [17MY]

——— expand tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis (see S. 3220), S5338 [2NO] (see H.R. 6227), H5404 [3NO]

——— prohibit vaccination mandates for coronavirus (see S. 167), S172 [31JA] (see H.R. 403), H248 [20JA]

——— treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review and require tests for active and latent tuberculosis during donor screening and testing (see H.R. 6705), H6814 [11DE]

Drugs: allow rejection of citizen petition if it is believed primary purpose of petition is to delay approval of pending drug application and refer such petitioners to FTC (see S. 1067), S1053 [29MR]

——— amend laws relative to 180-day exclusivity period (see S. 1114), S1089 [30MR]

——— amend mission statement to require agency to address nation’s prescription opioid addiction epidemic (see S. 604), S568 [1MR]

——— clarify process for denying certain petitions whose primary purpose is to delay approval of application submitted relative to certain drugs (see H.R. 3030), H2118 [28AP]

——— deny approval of new drug application for opioid analgesic drug on basis of such drug not being clinically superior to other commercially available drugs (see S. 607), S568 [1MR] (see H.R. 1375), H1113 [3MR]

——— enhance drug manufacturing amount information reporting (see H.R. 3810), H2740 [5JN]

——— ensure patients have access to certain urgent-use compounded medications (see H.R. 167), H104 [9JA]

——— establish procedures relative to approval of opioid drugs (see S. 603), S568 [1MR]

——— establish process to allow holders of abbreviated new generic drug applications to make labeling changes to include new or updated safety-related information (see H.R. 4134), H2932 [14JN]

——— establish time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products (see S. 1906), S2029 [8JN] (see H.R. 4408), H3157 [30JN]

——— expand certain authorities relative to recall of controlled substances to apply with respect to all drugs (see H.R. 2500), H1707 [6AP]

——— expressly authorize use of certain grants to implement substance use disorder and overdose prevention activities relative to fentanyl and xylazine test strips (see H.R. 4106), H2930 [14JN]

——— extend Federal support for bioindustrial manufacturing processes to include support for manufacturing of certain pharmaceutical ingredients (see H.R. 6895), H7006 [22DE]

——— improve requirements for making determination of interchangeability of biological product and its reference product (see S. 2305), S2460 [13JY]

——— limit exclusive approval or licensure of orphan drugs (see H.R. 456), H276 [24JA]

——— make certain changes relative to approval of abbreviated applications for approval of new animal drugs (see H.R. 1683), H1300 [21MR]

——— prohibit certain uses of xylazine (see S. 993), S999 [28MR] (see H.R. 1839), H1527 [28MR]

——— provide for mandatory recall authority over regulated drugs and homeopathic products (see H.R. 3688), H2636 [25MY]

——— provide for notification by manufacturers of critical essential medicines of increased demand of such drugs (see S. 2362), S2985 [18JY] (see H.R. 3008), H2117 [28AP]

——— provide increased transparency in generic drug applications (see S. 775), S771 [14MR] (see H.R. 3839), H2761 [6JN]

——— reauthorize certain programs to provide for opioid use disorder prevention, recovery, and treatment (see H.R. 4531), H3204 [11JY]

——— require manufacturers of life-saving drugs to submit data and information to assess stability of such drugs and determine their longest supported expiration date (see H.R. 3793), H2740 [5JN]

——— require research on fentanyl and xylazine test strips and authorize use of grant funds for such test strips (see S. 2919), S4678 [26SE]

——— require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to FDA and Patent and Trademark Office (see S. 2780), S4440 [13SE] (see H.R. 5429), H4296 [13SE]

——— revoke approval of one opioid pain medication for each new opioid pain medication approved (see S. 606), S568 [1MR]

——— set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions (see S. 1214), S1256 [19AP]

——— strengthen authority relative to foreign drug facility inspections (see S. 1134), S1090 [30MR]

——— strengthen use of patient-experience data within benefit-risk framework for approval of new drugs (see S. 526), S457 [16FE] (see H.R. 1092), H853 [17FE]

EPA: provide grants to reduce amount of food waste (see S. 177), S172 [31JA] (see H.R. 652), H574 [31JA]

Families and domestic relations: increase Federal support for nonprofit milk banks and access to donor milk for medically-vulnerable infants (see S. 2819), S4525 [14SE] (see H.R. 5486), H4345 [14SE]

FDA and Office of the U.S. Trade Representative: require reports on and investments in pharmaceutical supply chain resiliency to reduce reliance on China for finished pharmaceutical products and active pharmaceutical ingredients (see S. 2454), S3459 [20JY]

Federal agencies and departments: provide for greater accountability relative to Federal activities and expenditures relating to coronavirus (see H.R. 271), H202 [11JA]

Food: define term natural cheese (see S. 981), S954 [27MR] (see H.R. 1803), H1464 [27MR]

——— ensure safety of imported seafood (see H.R. 1057), H851 [17FE]

——— establish standard of identity for honey (see H.R. 4764), H3886 [20JY]

——— prohibit sale of poppy seeds, or food that contains poppy seeds, with unsafe levels of certain opiates (see S. 3354), S5674 [29NO] (see H.R. 6512), H5983 [29NO]

——— strengthen requirements related to nutrient information on food labels (see S. 1289), S1381 [26AP] (see S. 3512), S5961 [13DE] (see H.R. 2901), H2048 [26AP] (see H.R. 6766), H6941 [13DE]

FTC: deter filing of sham citizen petitions to cover attempt to interfere with approval of competing generic drug or biosimilar and foster competition and facilitate review of drug petitions filed in good faith (see S. 148), S147 [30JA]

Government regulations: allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food (see H.R. 4849), H3948 [25JY]

——— make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use as dietary ingredients in dietary supplements (see S. 2451), S3459 [20JY] (see H.R. 1629), H1292 [17MR]

——— repeal authority to require that drugs be dispensed only upon prescription (see H.R. 75), H100 [9JA]

Health: provide for regulation of in-vitro clinical tests (see H.R. 2369), H1640 [29MR]

——— provide marketing reciprocity to certain drugs, biological products, and medical devices authorized to be lawfully marketed abroad (see S. 1712), S1744 [18MY] (see H.R. 3532), H2455 [18MY]

Insurance: require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives (see S. 1698), S1743 [18MY] (see H.R. 3589), H2500 [22MY]

Interstate commerce: authorize regulation relative to food containing cannabidiol derived from hemp (see H.R. 1628), H1292 [17MR]

Kratom: protect access (see S. 3039), S4948 [4OC] (see H.R. 5905), H4990 [6OC]

Labeling: codify definition of beef for labeling purposes, reinforce existing misbranding provisions to eliminate consumer confusion, and enhance Dept. of Agriculture labeling enforcement measures (see S. 3281), S5458 [9NO]

——— establish requirements for quality and discard dates voluntarily declared on food labels (see S. 1484), S1566 [9MY] (see H.R. 3159), H2171 [9MY]

——— expand types of devices for which required labeling may be made available solely by electronic means (see H.R. 3723), H2638 [25MY]

——— permit manufacturers to provide additional warnings on generic drugs in same manner as brand name drugs (see S. 2886), S4654 [21SE]

——— provide authority to prohibit water buffalo products from being marketed as buffalo and clarify that buffalo is common name for bison (see S. 258), S230 [2FE] (see H.R. 3866), H2762 [6JN]

——— require enforcement of labeling regulations against misbranded imitation dairy products such as milk, cheese, or yogurt (see S. 549), S531 [28FE] (see H.R. 1462), H1205 [8MR]

——— require label of drug intended for human use to identify each ingredient that is, or is derived directly or indirectly from, major food allergen or gluten-containing grain (see S. 2079), S2185 [21JN] (see H.R. 4263), H3071 [21JN]

Marijuana: provide for new rules on regulation of marijuana (see H.R. 6673), H6740 [7DE]

Medical devices: amend device shortage notifications (see H.R. 3807), H2740 [5JN]

——— establish electronic format for medical device recall notifications (see S. 2907), S4654 [21SE] (see H.R. 5662), H4456 [21SE]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 71), H100 [9JA]

——— require manufacturers to provide notification of design or cleaning instruction changes and safety warnings issued in foreign countries about design and cleaning (see H.R. 1090), H853 [17FE]

Medicare: provide coverage of FDA-approved qualifying colorectal cancer screening blood-based tests, increase participation in communities of color, and offset coronavirus pandemic driven decline in colorectal screenings (see S. 892), S859 [21MR]

Mental health: issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy (see H.R. 4242), H3070 [21JN]

Office of Food Safety Reassessment: establish (see H.R. 3927), H2778 [7JN]

Packaging: deem certain substances to be unsafe for use as food contact substances (see H.R. 6105), H5174 [26OC]

Patents: establish interagency task force between Patent and Trademark Office and FDA for sharing information and providing technical assistance relative to patents (see S. 79), S98 [25JA] (see H.R. 1717), H1326 [22MR]

Pediatric Research Site Network: provide for establishment and maintenance (see H.R. 5269), H4203 [25AU]

Pharmaceuticals: allow digital communication of prescribing information for drugs, including biological products (see S. 2916), S4678 [26SE] (see H.R. 1503), H1248 [9MR]

——— clarify that artificial intelligence and machine learning technologies can qualify as practitioner eligible to prescribe drugs if State authorized and FDA approved, cleared, or authorized (see H.R. 206), H105 [9JA]

——— determine whether to permit use of enriched enrollment randomized withdrawal methodology relative to clinical trials (see S. 2737), S4270 [7SE]

——— encourage innovation in development of pediatric drugs and ensure drugs for rare diseases are studied in children and drug companies are accountable for completing pediatric study requirements (see H.R. 6664), H6739 [7DE]

——— end dependence on Chinese pharmaceuticals by encouraging growth of robust domestic medicine supply chain for generic drugs and empower FDA to issue warnings for critical contaminations (see H.R. 5575), H4407 [19SE]

——— establish emerging pathogen preparedness program to improve regulatory oversight of medical countermeasures for future pandemics (see S. 2329), S2461 [13JY]

——— establish postmarket reporting requirements (see S. 3143), S5213 [26OC] (see H.R. 6112), H5174 [26OC]

——— establish requirements for purchasing certain generic drugs from manufacturers who produce drug domestically (see S. 2683), S3756 [27JY]

——— establish special rules allowing generic manufacturers to sue brand-name manufacturers who overstate applications concerning method of use patents (see S. 1128), S1090 [30MR]

——— improve actions available to eligible product developers in event of delays in receiving covered product for purposes of generic drug or biosimilar biological product development (see S. 1120), S1090 [30MR]

——— improve priority review process of human drug applications to encourage treatment for agents that present national security threats (see S. 1122), S1090 [30MR] (see H.R. 5708), H4497 [26SE]

——— modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (see H.R. 4988), H4138 [27JY]

——— preserve access to abortion medications (see H. Con. Res. 33), H1725 [13AP]

——— prohibit prescription drug manufacturers from compensating other companies to delay entry of generic drugs, biosimilar biological products, or interchangeable biological products into market (see S. 142), S147 [30JA] (see H.R. 6275), H5544 [7NO]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: reauthorize (see S. 3393), S5712 [4DE]

——— reauthorize certain programs (see S. 2433), S3459 [20JY] (see S. 3106), S5143 [24OC]

——— reauthorize youth prevention and recovery initiative (see S. 3070), S5087 [18OC] (see H.R. 5598), H4437 [20SE]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in sale, manufacturing, and distribution of cigars (see S. 107), S120 [26JA] (see H.R. 1486), H1247 [9MR]

——— exempt premium cigar industry from certain regulations (see H.J. Res. 99), H5669 [9NO]

——— prioritize enforcement against disposable electronic nicotine delivery system products containing flavors (see H.R. 901), H823 [9FE]

Letters

Animal Drug User Fee Act reauthorization performance goals and procedures fiscal year 2024 through 2028, S5038–S5042 [17OC]

Animal Generic User Fee Act reauthorization performance goals and procedures fiscal year 2024 through 2028, S5042 [17OC]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4368), H4510 [26SE], H4849 [28SE]

Remarks in House

Abortion: nullify modifications made to risk evaluation and mitigation strategy for abortion pill mifepristone, H4510 [26SE]

——— preserve access to abortion medications, H472 [27JA]

——— prohibit use and distribution of abortion drugs, H3901 [25JY]

——— Texas Federal district court decision in Alliance for Hippocratic Medicine v. FDA relative to approval of abortion pill mifepristone, H1743 [17AP], H1768, H1790 [18AP], H1874 [19AP], H1889, H1896, H1898 [20AP]

——— Texas Federal district court hearing of Alliance for Hippocratic Medicine v. FDA relative to approval of abortion pill mifepristone, H1236 [9MR]

Agriculture, rural development, FDA, and related agencies programs: across-the-board funding reduction, H4565 [26SE]

——— making appropriations (H.R. 4368), H3901, H3904, H3906, H3944 [25JY], H3960, H3962, H3965, H3966, H4017–H4020 [26JY], H4037, H4058 [27JY], H4505–H4566 [26SE], H4649–H4659 [27SE], H4719, H4849 [28SE], E909, E916 [29SE], E924 [2OC]

——— making appropriations (H.R. 4368), consideration (H. Res. 723), H4480–H4495 [26SE]

Animals: reauthorize user fee programs relating to new animal drugs and generic new animal drugs (H.R. 1418), H3620–H3624 [17JY]

Center for Drug Evaluation and Research: reduce salary of Director, H4559 [26SE]

Contraceptives: allow women greater access to wider range of self-administered contraceptives (H.R. 1512), H1263 [10MR]

——— encourage sponsors of oral contraceptive drugs to submit applications for approval of such drugs as over-the-counter (H.R. 4626), H3617 [17JY]

Dept. of Veterans Affairs: conduct studies into efficacy of drugs that have FDA-designated Breakthrough Therapy status to treat post-traumatic stress disorder, H3996 [26JY]

Diesase and disorders: approval of Leqembi to treat Alzheimer’s disease patients, H3183 [11JY]

Division of Risk Management: reduce salary of Director, H4562 [26SE]

Drugs: provide for opioid use disorder prevention, recovery, and treatment, H2580 [24MY]

——— reauthorize certain programs to provide for opioid use disorder prevention, recovery, and treatment (H.R. 4531), H6789–H6798 [11DE], H6821 [12DE]

Federal agencies and departments: provide for greater accountability relative to Federal activities and expenditures relating to coronavirus (H.R. 271), H159 [11JA]

Government regulations: make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use as dietary ingredients in dietary supplements (S. 2451), E705 [24JY]

——— proposed rule to ban use of menthol in cigarettes and flavored cigars, H5715 [13NO], E1241 [15DE]

Health: support patient access to gene therapy treatments for rare diseases, E932 [3OC]

Labeling: require enforcement of labeling regulations against misbranded imitation dairy products such as milk, cheese, or yogurt (H.R. 1462), H1303 [22MR]

Office of Compliance: reduce salary of Director, H4562 [26SE]

Office of Medical Policy: reduce salary of Director, H4563 [26SE]

Office of New Drugs: reduce salary of Director, H4562 [26SE]

Office of Regulatory Policy: reduce salary of Director, H4563 [26SE]

Office of Surveillance and Epidemiology: reduce salary of Director, H4561 [26SE]

Pharmaceuticals: modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (H.R. 4988), H5973 [29NO]

——— preserve access to abortion medications, H1743 [17AP], H1874, H1875 [19AP], H1889, H1896, H1898 [20AP]

——— prohibit funding for grants relative to any transgenic edible vaccine, H4559, H4560 [26SE]

Research: tribute to advancements in gene therapy research, E830 [12SE]

Tobacco products: address rise in use of e-cigarettes, H586 [1FE]

——— impose additional restrictions on tobacco flavors for use in e-cigarettes, H769 [8FE], H805 [9FE]

Unapproved Drugs Initiative: prohibit implementation funding, H4542 [26SE]

Remarks in Senate

Abortion: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine, S68, S69 [24JA]

——— preserve access to abortion medications, S630 [2MR]

——— Texas Federal district court decision in Alliance for Hippocratic Medicine v. FDA relative to approval of abortion pill mifepristone, S1123 [17AP]

——— Texas Federal district court hearing of Alliance for Hippocratic Medicine v. FDA relative to approval of abortion pill mifepristone, S416 [15FE], S438–S441 [16FE], S836 [16MR]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4368), S4433–S4435 [13SE], S5128 [24OC]

——— making appropriations (H.R. 4368), unanimous-consent request, S4504 [14SE]

Animals: reauthorize user fee programs relating to new animal drugs and generic new animal drugs (S. 1844), S5038 [17OC]

Diseases and disorders: prohibit vaccination mandates for coronavirus (S. 167), S248 [7FE]

Drugs: establish time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, S412 [15FE]

Government regulations: proposed rule to ban use of menthol in cigarettes and flavored cigars, S5770 [6DE]

Pharmaceuticals: prohibit prescription drug manufacturers from compensating other companies to delay entry of generic drugs, biosimilar biological products, or interchangeable biological products into market (S. 142), S218 [2FE]

Tobacco products: address rise in use of e-cigarettes, S108 [26JA], S4340 [11SE]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 4368) (H. Rept. 118–124), H3149 [27JN]

——— Committee on Appropriations (Senate) (S. 2131) (S. Rept. 118–44), S2221 [22JN]

Consideration of H.R. 4368, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 723) (H. Rept. 118–216), H4496 [26SE]

Ensuring Timely Access to Generics Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1067), S2221 [22JN]

Expanding Access to Low-Cost Generics Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1114), S2221 [22JN]

FDA User Fee Programs Relating to New Animal Drugs and Generic New Animal Drugs Reauthorization: Committee on Energy and Commerce (House) (H.R. 1418) (H. Rept. 118–104), H2785 [9JN]

——— Committee on Health, Education, Labor, and Pensions (Senate) (S. 1844), S3618 [26JY]

Interagency Patent Coordination and Improvement Act: Committee on the Judiciary (Senate) (S. 79), S567 [1MR]

Preserve Access to Affordable Generics and Biosimilars Act: Committee on the Judiciary (Senate) (S. 142), S567 [1MR]

Retaining Access and Restoring Exclusivity (RARE) Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1214), S2221 [22JN]

Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act: Committee on the Judiciary (Senate) (S. 148), S567 [1MR]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4368), consideration (H. Res. 723), H4481 [26SE]

Texts of

H. Res. 723, consideration of H.R. 4368, agriculture, rural development, FDA, and related agencies programs appropriations, H4480 [26SE]

H.R. 1418, FDA user fee programs relating to new animal drugs and generic new animal drugs reauthorization, H3620–H3623 [17JY]

H.R. 4368, agriculture, rural development, FDA, and related agencies programs appropriations, H4511–H4524 [26SE]

H.R. 4531, certain programs to provide for opioid use disorder prevention, recovery, and treatment reauthorization, H6790–H6794 [11DE]

S. 79, Interagency Patent Coordination and Improvement Act, S102 [25JA]

S. 2907, Medical Device Recall Improvement Act, S4658 [21SE]

S. Res. 510, respect FDA scientific judgement that mifepristone is safe and effective and ensure access to lifesaving, time-sensitive medication abortion care in U.S. is equitable and based on science, S6004 [14DE]