FDA Drugs · Jun 12, 2026
Emergency IND Timeline
Information is intended to provide an overview of timelines applicable to physicians who plan to submit or have submitted individual patient expanded access applications for emergency use.
Drugs & FDA · page 2
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jun 12, 2026
IND Application Reporting: Safety Reports
IND Application Reporting: Safety Reports
FDA Drugs · Jun 12, 2026
FDA Name Differentiation Project
The Office of Generic Drugs requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order to minimize medication errors resulting from look-alike confusion.
FDA Drugs · Jun 12, 2026
Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop - 09/25/2026
Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop
FDA Drugs · Jun 12, 2026
FDA Drug Competition Action Plan
FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
FDA Drugs · Jun 12, 2026
Forms FDA 3542a and FDA 3542: Questions and Answers
Forms FDA 3542a and FDA 3542: Questions and Answers
FDA Drugs · Jun 11, 2026
Frequently Requested or Proactively Posted Drug-Specific and Other Records
Frequently requested or proactively posted drug-specific and other records
FDA Drugs · Jun 11, 2026
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.
FDA Drugs · Jun 11, 2026
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
International Council for Harmonisation - Safety
FDA Drugs · Jun 11, 2026
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/23/2026
FDA's annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments” will be held on June 23, 2026
FDA Drugs · Jun 11, 2026
Registered Outsourcing Facilities
Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.
FDA Drugs · Jun 11, 2026
Human Drug Compounding Policies and Rules
List of compounding policy documents and related materials
FDA Drugs · Jun 11, 2026
Human Drug Compounding Outsourcing Facility Fees
Human Drug Compounding Outsourcing Facility Fees
FDA Drugs · Jun 11, 2026
Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
FDA Newsroom · Jun 11, 2026
FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.
FDA Drugs · Jun 10, 2026
New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Discover potential signals of serious risks and new safety information identified by the FDA's Adverse Event Monitoring System (AEMS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.
FDA Drugs · Jun 10, 2026
FDA notification regarding unapproved drugs included in kits
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
FDA Drugs · Jun 10, 2026
Business Pill may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Business Pill, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.
FDA Drugs · Jun 10, 2026
Branch Manager for Men may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Branch Manager for Men, a product promoted and sold for male sexual enhancement on various websites, including https://supplx.com, and possibly in some retail stores.
FDA Drugs · Jun 10, 2026
Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
FDA Drugs · Jun 10, 2026
FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using
FDA Drugs · Jun 10, 2026
Drug Repurposing
Drug repurposing refers to the identification of potential new uses – e.g., a new indication or a new population – of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.
FDA Drugs · Jun 10, 2026
CDER Small Business and Industry Assistance (SBIA) Learn
SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.
FDA Drugs · Jun 10, 2026
CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation