Search

September 1, 2020 Contents Background Federal Role in Overseeing the Medical Supply Chain Scope of This Report Registration and Listing Requirements for Drugs and Devices Establishment Registration Requirements Listing Requirements [...]

Updated September 22, 2020 The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain globally and domestically. The impact of COVID-19 on the availability of personal protective [...]

Contents Introduction Regulation and Oversight of U.S. Blood Supply FDA Regulation of the Blood Supply Oversight of the U.S. Blood Supply Industry and Federal Response to COVID-19 FDA Guidance to [...]

June 25, 2020 In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with the United States now reporting the highest number of cases of any country in [...]

Updated May 27, 2020 To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics--drugs or biologics--for the treatment of COVID-19. However, FDA has authorized the emergency [...]

April 29, 2020 Contents Introduction A Snapshot of CARES Act Health Provisions Report Contents Definitions, Abbreviations, and Acronyms 'Section 319' Public Health Emergency Additional Definitions and Acronyms CARES Act Health [...]

Updated April 2, 2020 Contents FDA Overview Funding Sources FDA Funding History and FY2020 Appropriations Figures Figure 1. FDA Spending, by Source, FY1992-FY2019 Tables Table 1. Food and Drug Administration [...]

March 25, 2020 Contents Introduction Lead-Up to Enactment Overview of the Supplemental Health and Human Services (HHS) Food and Drug Administration (FDA) Centers for Disease Control and Prevention (CDC) National [...]

Updated March 2, 2020 Contents Background Epidemiology of COVID-19 Domestic Response Investigation and Control of COVID-19 Cases in the Community The Role of Laboratories in Testing Travel-Related Policies and Restrictions [...]

Updated February 10, 2020 Cannabidiol (CBD) is promoted as treatment for a range of conditions, including anxiety, pain, inflammation, and posttraumatic stress disorder--despite limited scientific evidence to substantiate or disprove [...]

December 4, 2019 Prior to being marketed in the United States, medical products are reviewed for safety and effectiveness, among other things, by the Food and Drug Administration (FDA). Medical [...]

Contents What is human fetal tissue? What are the uses of human fetal tissue in biomedical laboratory research? What are the alternatives to fetal tissue in laboratory research? What is [...]

Updated June 6, 2019 Contents Introduction FDA Regulation of Biologics Events Leading Up to Biosimilars Legislation New Regulatory Pathway for Biosimilars Approval and Marketing of Biosimilars Patent Litigation and Settlements [...]

THE PHARMACEUTICAL DRUG DEVELOPMENT PROCESS The pharmaceutical drug development process includes three stages: research and development (R&D), approval, and postmarketing. On average, drugs take 10-15 years from discovery to approval. [...]

Contents Introduction Overarching S&T Policy Issues Federal Science and Technology Policymaking Enterprise Federal Funding for Research and Development Disruptive and Convergent Technology America COMPETES Act Reauthorization Technology Transfer from Federal [...]

January 17, 2019 A variety of proposals to address high drug prices have been introduced in legislation and by the Trump Administration in its blueprint to lower drug prices. According [...]

January 28, 2019 The Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and devices ('medical products') pursuant to its authorities under the Federal Food, Drug [...]

December 27, 2018 Drug shortages have remained a serious and persistent public health concern, despite the prevention and mitigation efforts of Congress, the Food and Drug Administration (FDA), and health [...]

Updated November 15, 2018 Contents Introduction Budgetary Impact Related Prior Laws SUPPORT Act Organization Title III--FDA and Controlled Substance Provisions Subtitle A--FDA Provisions Chapter 1--In General Section 3001. Clarifying FDA [...]

Under most circumstances, drugs, medical devices, and biologics may only be introduced into interstate commerce if they have been approved, cleared, or licensed by the Food and Drug Administration (FDA). [...]

Updated May 22, 2018 Contents Introduction Overarching S&T Policy Issues Federal Science and Technology Policymaking Enterprise Federal Funding for Research and Development America COMPETES Act Reauthorization Regulations for Federally Funded [...]

Updated May 8, 2018 Contents Legislative History of Drug Regulation How FDA Approves New Drugs The Standard Process of Drug Approval Investigational New Drug (IND) Application Clinical Trials New Drug [...]

Updated March 16, 2018 Contents Introduction Origin of Prescription Drug User Fees Current Law FDA Drug Review and PDUFA Coverage Prescription Drug User Fees Fee Types Fee Adjustments Conditions (or [...]

Updated March 16, 2018 Contents Introduction History of FDA Drug Regulation Early FDA Risk Management Programs Risk Evaluation and Mitigation Strategies (REMS) Elements of REMS Examples of Approved REMS Impact [...]

Contents Introduction Obesity and Menu Labeling Research Evaluating the Impact of Menu Labeling Studies of the Impact of Menu Labeling on Calories Purchased Studies of the Impact of Menu Labeling [...]

Updated January 5, 2018 Contents Background Legislative History Pharmacy Compounding FFDCA Section 503A Outsourcing Facility Compounding FFDCA Section 503B CQA Implementation and Possible Issues for Congress The Prescription Requirement and [...]