Drug approval -- United States
Label
Drug approval -- United States
Name
Drug approval
Focus
Sub focus
Actions
Incoming Resources
- Drugs@FDA
- Guidance for industry, variations in drug products that may be included in a single ANDA
- Guidance for industry, referencing discontinued labeling for listed drugs in abbreviated new drug applications
- Committee prints on administration legislative proposals on the Animal Drug User Fee Act Amendments of 2008 and the Animal Generic Drug User Fee Act of 2008, hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, June 5, 2008
- Guidance for industry, major, minor, and telephone amendments to abbreviated new drug applications
- Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages, hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012
- Guidance for industry, changes to an approved NDA or ANDA
- Guidance for industry, providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Opioid Review Modernization Act of 2016, report (to accompany H.R. 4976) (including cost estimate of the Congressional Budget Office)
- Guidance for industry, court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act
- New drug development, science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to congressional requesters
- The administration's FDA reforms and reduced biopharmaceutical drug prices, The Council of Economic Advisers
- Guidance for industry, providing regulatory submissions in electronic format, general considerations
- FDA drug approval, application review times largely reflect FDA goals : report to congressional requesters
- FDA user fees, advancing public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... July 28, 2011
- Off-label drug use and FDA review of supplemental drug applications, hearing before the Subcommittee on Human Resources and Intergovernmental Relations of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, second session, September 12, 1996
- Improving Regulatory Transparency for New Medical Therapies Act
- Guidance for industry, revising and ANDA labeling following revision of the RLD labeling
- FDA checkup, drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013
- Guidance for FDA reviews and sponsors, content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
- Guidance for industry, formal dispute resolution, appeals above the division level
- FDA user fee agreements, strengthening FDA and the medical products industry for the benefit of patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, second session ... March 29, 2012
- Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products
- Guidance for industry, NDA's : impurities in drug substances
- Guidance for industry, changes to an approved application for specified biotechnology and specified synthetic biological products
- PDUFA V, medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, July 7, 2011
- Guidance for industry, classifying resubmissions in response to action letters
- Guidance for industry, PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection
- E 16 genomic biomarkers related to drug response, context, structure, and format of qualification submissions
- Antitrust concerns and the FDA approval process, hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017
- Guidance for industry, botanical drug products
- Improving Regulatory Transparency for New Medical Therapies Act, report (to accompany H.R. 4299) (including cost estimate of the Congressional Budget Office)
- Guidance for industry, changes to an approved NDA or ANDA, questions and answers
- Unlocking hope, access to therapies for people with rare, progressive, and serious diseases : hearing before the Special Committee on Aging, United States Senate, One Hundred Eighteenth Congress, first session, Washington, DC, October 26, 2023
- Continuing America's leadership, advancing research and development for patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, first session ... March 24, 2015
- FDA user fee agreements: advancing medical product regulation and innovation for the benefit of patients, FDA center directors, hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventeenth Congress, second session on examining Food and Drug Administration user fee agreements, focusing on advancing medical product regulation and innovation for the benefit of patients and Food and Drug Administration center directors, April 26, 2022
- Guidance for industry, alternate source of the active pharmaceutical ingredient in pending ANDAs
- Developments in the prescription drug market, oversight : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016
- Perspectives of drug manufacturers, investigational new drug and new drug applications
- European Union: authorization of drugs already approved in the United States, Theresa Papademetriou
- Amending the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs, report (to accompany H.R. 1407) (including cost estimate of the Congressional Budget Office)
- The impact of medical device and drug regulation on innovation, jobs, and patients, a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011
- Guidance for industry, listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers
- Guidance for industry, submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry, changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
- Guidance for FDA reviews and sponsors, content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
- Improving predictability and transparency in DEA and FDA regulation, hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, April 7, 2014
- Guidance for industry, qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
- FDA user fee agreements, improving medical product regulation and innovation for patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, first session on ... March 21, 2017
- Perspectives of drug manufacturers, abbreviated new drug applications
Outgoing Resources
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