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1. www.fda.govU.S. Food and Drug Administration

   www.fda.gov

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   Help Stop the Spread of Misinformation. You can help. Get the facts from the FDA. Stop the spread of false rumors, and share the facts with your loved ones. Vaccination is the Best Protection...

2. www.fda.gov › news-events › press-announcementsFDA Warns Consumers to Avoid Certain Male Enhancement and ...

   www.fda.gov › news-events › press-announcements

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   2021年12月8日 · On July 26, 2021, the FDA issued an untitled letter to notify Amazon about its distribution of sexual enhancement and weight loss products in violation of the Federal Food, Drug, and Cosmetic Act.

3. www.fda.gov › drugsDrugs | FDA

   www.fda.gov › drugs

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   Navigate the Drugs Section. Drug Information, Safety, and Availability. Medication Guides, Drug Safety Communications, Shortages, Recalls. Drug Approvals and Databases. Drugs@FDA, Orange Book,...

4. www.fda.gov › cosmetics › registration-listing-cosmeticRegistration & Listing of Cosmetic Product Facilities ...

   www.fda.gov › cosmetics › registration-listing-cosmetic

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   2023年9月15日 · The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was...

5. www.fda.gov › drugs › types-applicationsInvestigational New Drug (IND) Application | FDA

   www.fda.gov › drugs › types-applications

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   • Introduction
   • Resources For Ind Applications
   • Emergency Use of An Investigational Drug Or Biologic

   Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through w...

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   The following resources include the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures. Pre-IND Consultation Program CDER's Pre-Investigational New Drug Application (IND) Consultation Programfosters early communications between sponsors and ...

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   Emergency Use of an Investigational Drug or Biologic - Information Sheet

   The Guidance for Institutional Review Boards and Clinical Investigatorscontains information on: Obtaining an Emergency IND, Emergency Exemption from Prospective IRB, Approval Exception from Informe...

   Physician Request for a Single Patient IND for Compassionate or Emergency Use

   Instructions for Sponsors of Emergency Investigational New Drug (EIND) Applications for Antimicrobial Products. From the Office of Antimicrobial Products, Division of Antiviral Products

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6. www.fda.gov › medical-devices › global-unique-deviceRequest a GUDID Account | FDA

   www.fda.gov › medical-devices › global-unique-device

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   Request a GUDID Account. Labelers of all classes of medical devices currently marketed in the United States may obtain a GUDID account. Before you begin Device labelers must complete all steps...

7. www.fda.gov › news-events › expanded-accessHow to Complete Form FDA 1571 and Form FDA 1572 | FDA - U.S. ...

   www.fda.gov › news-events › expanded-access

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   2019年11月13日 · Share. On this page, you will find information about completing Form FDA 1571 and Form FDA 1572. Form FDA 3926 can be used by physicians when submitting requests for individual patient expanded...