Antitrust Concerns and the FDA Approval Process.

FDA Risk Evaluation and Mitigation Strategies (REMS) : description and effect on generic drug development /
by: Dabrowska, Agata
Published: (2018)

High-stakes antitrust : the last hurrah? /
Published: (2003)

The federal antitrust laws : with summary of cases instituted by the United States and lists of cases decided thereunder.
Published: (1938)

Prioritizing Public Health : The FDA's Role in the Generic Drug Marketplace : Special Hearing.
Published: (2016)

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.
Published: (2018)

How FDA approves drugs and regulates their safety and effectiveness /
by: Dabrowska, Agata
Published: (2018)

FDA-approved bargain drugs : generic products must meet high standards.
Published: (2003)

Examining the Impact of Voluntary Restricted Distribution Systems in the Pharmaceutical Supply Chain.
Published: (2017)

The federal antitrust laws with amendments : list of cases instituted by the United States and citations of cases decided thereunder or relating thereto.
Published: (1928)

The federal antitrust laws with amendments : list of cases instituted by the United States and citations of cases decided thereunder or relating thereto.
Published: (1931)

FDA regulation of laboratory-developed tests (LDTs) /
by: Sarata, Amanda K.
Published: (2020)

FDA in the twenty-first century : the challenges of regulating drugs and new technologies /
Published: (2015)

FDA's generic drug approval process : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, first session.
Published: (1989)

FDA Checkup : Drug Development and Manufacturing Challenges.
Published: (2013)

Generic Drug User Fee Amendments : Accelerating Patient Access to Generic Drugs.
Published: (2016)

FDA's foreign drug inspection program : weaknesses place Americans at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, April 22, 2008.
Published: (2008)

FDA User Fees 2012 : Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development, and Downstream Pharmaceutical Supply Chain.
Published: (2012)

Examining the Increase in Drug Shortages.
Published: (2011)

Proposed FDA user fee acts : Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA) /
by: Thaul, Susan, et al.
Published: (2019)

FDA's generic drug application policy : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundredth Congress, second session, July 28, 1988.
Published: (1989)

Antitrust and the iPhone : Supreme Court to consider whether app store customers can sue Apple for monopolization /
by: Sykes, Jay B.
Published: (2018)

Improving Predictability and Transparency in DEA and FDA Regulations.
Published: (2014)

Definitions and standards for food products.
Published: (1932)

[Budget activities of Veterans Administration; text of order].
Published: (1930)

[Finance activities of Veterans Administration; text of order].
Published: (1930)

FDA User Fees 2012 : How Innovation Helps Patients and Jobs.
Published: (2012)

Generic drugs : stakeholders views on improving FDA's information on patents : report to congressional committees /
Published: (2023)

FDA Amendments Act of 2007 (P.L. 110-85) /
by: Thaul, Susan
Published: (2018)

Drug safety: FDA should take additional steps to improve its Foreign Inspection Program : report to congressional requesters.
Published: (2022)

FDA User Fee Agreements : Improving Medical Product Regulation and Innovation for Patients.
Published: (2017)

Drug compounding: FDA authority and possible issues for Congress : other title information /
by: Dabrowska, Agata
Published: (2018)

Las drogas baratas aprobadas por la FDA : los productos genéricos deben satisfacer altos niveles.
Published: (2004)

Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization /
by: Thaul, Susan
Published: (2018)

FDA User Fee Agreements : Strengthening FDA and the Medical Products Industry for the Benefit of Patients.
Published: (2012)

Examining FDA's Role in the Regulation of Genetically Modified Food Ingredients.
Published: (2014)

Antitrust regulators release new vertical merger guidelines /
by: Sykes, Jay B.
Published: (2020)