Drug approval -- United States
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The concept Drug approval -- United States represents the subject, aboutness, idea or notion of resources found in Biddle Law Library - University of Pennsylvania Law School.
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Drug approval -- United States
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The concept Drug approval -- United States represents the subject, aboutness, idea or notion of resources found in Biddle Law Library - University of Pennsylvania Law School.
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- Drug approval -- United States
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- AIDS, experimental drug approval, and the FDA new drug screening process : a legal research guide
- 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)
- An Act to Amend the Federal Food, Drug, and Cosmetic Act to Provide an Alternative Process for Review of Safety and Effectiveness of Nonprescription Sunscreen Active Ingredients, and for Other Purposes
- An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the Animal Drug User Fee Program, to Establish a Program of Fees Relating to Generic New Animal Drugs, to Make Certain Technical Corrections to the Food and Drug Administration Amendments Act of 2007, and for Other Purposes
- An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the Animal Drug User Fee Program, to Establish a Program of Fees Relating to Generic New Animal Drugs, to Make Certain Technical Corrections to the Food and Drug Administration Amendments Act of 2007, and for Other Purposes
- An Act to Expand the Program of Priority Review to Encourage Treatments for Tropical Diseases
- Animal Drug User Fee Amendments of 2008 : report (to accompany H.R. 6432) (including cost estimate of the Congressional Budget Office)
- Animal Generic Drug User Fee Act of 2008 : report (to accompany H.R. 6433) (including cost estimate of the Congressional Budget Office)
- Animal drug user fee agreements : advancing animal health for the public : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013
- 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
- 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
- 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
- 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
- Dose-response information to support drug registration
- Drugs@FDA
- E 16 genomic biomarkers related to drug response : context, structure, and format of qualification submissions
- Examining FDA's Prescription Drug User Fee program : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, first session, March 22, 2017
- 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
- FDA drug approval : review time has decreased in recent years : report to Congressional requesters
- FDA regulatory affairs
- FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
- 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
- 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
- FDA user fees 2012 : how innovation helps patients and jobs : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, April 18, 2012
- FDA user fees 2012 : issues related to accelerated approval, medical gas, antibiotic development, and downstream pharmaceutical supply chain : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, March 8, 2012
- 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
- Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016
- 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 : 180-day exclusivity when multiple ANDAs are submitted on the same day
- Guidance for industry : ANDAs, impurities in drug products
- Guidance for industry : ANDAs, impurities in drug substances
- Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information
- Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information
- Guidance for industry : M2, eCTD specification, questions & answers and change requests
- Guidance for industry : NDA's : impurities in drug substances
- 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
- Guidance for industry : Q3A impurities in new drug substances
- Guidance for industry : accelerated approval products, submission of promotional materials
- Guidance for industry : advisory committees : implementing Section 120 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry : alternate source of the active pharmaceutical ingredient in pending ANDAs
- Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval
- Guidance for industry : botanical drug products
- Guidance for industry : changes to an approved NDA or ANDA
- Guidance for industry : changes to an approved NDA or ANDA, questions and answers
- Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
- Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products
- Guidance for industry : classifying resubmissions in response to action letters
- Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information
- Guidance for industry : court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : formal dispute resolution, appeals above the division level
- 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 : major, minor, and telephone amendments to abbreviated new drug applications
- Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Guidance for industry : providing regulatory submissions in electronic format, general considerations
- Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : referencing discontinued labeling for listed drugs in abbreviated new drug applications
- Guidance for industry : revising and ANDA labeling following revision of the RLD labeling
- 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 : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry : variations in drug products that may be included in a single ANDA
- Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products
- Improving Regulatory Transparency for New Medical Therapies Act
- Improving Regulatory Transparency for New Medical Therapies Act : report (to accompany H.R. 4299) (including cost estimate of the Congressional Budget Office)
- Improving Regulatory Transparency for New Medical Therapies Act : report (to accompany H.R. 639)
- Improving animal health : reauthorization of FDA animal drug user fees : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, second session, on examining improving animal health, focusing on reauthorization of Food and Drug Administration animal drug user fees, February 13, 2018
- 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
- Issues relating to ephedra-containing dietary supplements : hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Commerce, Trade, and Consumer Protection of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, first session, July 23 and 24, 2003
- Ketek clinical study fraud : what did Aventis know? : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, February 12, 2008
- New drug approval : FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate
- New drug approval : FDA's consideration of evidence from certain clinical trials : report to congressional requesters
- New drug development : science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to conggressional requesters
- 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
- Opioid Review Modernization Act of 2016 : report (to accompany H.R. 4976) (including cost estimate of the Congressional Budget Office)
- 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
- Purple Book Continuity Act of 2019 : report (to accompany H.R. 1520) (including cost estimate of the Congressional Budget Office)
- RU-486 : demonstrating a low standard for women's health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, May 17, 2006
- 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
- Reviewing FDA's implementation of FDASIA : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, November 15, 2013
- Sunscreen Innovation Act : report (to accompany H.R. 4250) (including cost estimate of the Congressional Budget Office)
- The administration's FDA reforms and reduced biopharmaceutical drug prices
- 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
- User fees and refunds for premarked approval applications
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.law.upenn.edu/resource/o_uAdkvWOmA/" typeof="CategoryCode http://bibfra.me/vocab/lite/Concept"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.law.upenn.edu/resource/o_uAdkvWOmA/">Drug approval -- United States</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.law.upenn.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.law.upenn.edu/">Biddle Law Library - University of Pennsylvania Law School</a></span></span></span></span></div>
