FDA Drugs · Jun 9, 2026
Laboratorios Dr. Collado S.A. - 723285 - 06/02/2026
CGMP/OTC Finished Pharmaceuticals/Adulterated
Drugs & FDA · page 4
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jun 9, 2026
Asanuma Corporation - 721136 - Sagamihara Factory
CGMP/OTC Finished Pharmaceuticals/Adulterated
FDA Drugs · Jun 9, 2026
Erkul Kozmetik Sanayi ve Ticaret A.S. - 721964 - 06/02/2026
CGMP/OTC Finished Pharmaceuticals/Adulterated
FDA Drugs · Jun 9, 2026
Shantou Qiwei Industry Co., LTD - 721753 - 06/02/2026
CGMP/OTC Finished Pharmaceuticals/Adulterated
FDA Drugs · Jun 9, 2026
PLZ Corp - 721140 - 06/02/2026
CGMP/OTC Finished Pharmaceuticals/Adulterated
FDA Drugs · Jun 9, 2026
Revlon Group Holdings, LLC - 722596 - 06/02/2026
CGMP/OTC Finished Pharmaceuticals/Adulterated
FDA Drugs · Jun 9, 2026
Macau-Union Pharmaceutical Limited - 724506 - 05/29/2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs/Misbranded
FDA Drugs · Jun 9, 2026
Jose M. Carpio, M.D. - 730966 - 05/28/2026
Clinical Investigator
FDA Drugs · Jun 9, 2026
Frequently Requested or Proactively Posted Compliance Records
Frequently requested inspection records of foreign pharmaceutical manufacturing facilities
Drugs@FDA · Jun 9, 2026
FDA expands Ebglyss (lebrikizumab-lbkz) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Eli Lilly And Co
FDA Drugs · Jun 8, 2026
Over-The-Counter (OTC) Heartburn Treatment
There are three classes of OTC medications for the treatment of heartburn. Learn more.
FDA Drugs · Jun 8, 2026
Generic Drug Facilities, Sites and Organization Lists
Generic Drug Facilities, Sites and Organization Lists
FDA Drugs · Jun 8, 2026
FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds - 08/25/2026
On August 25, 2026, the U.S. Food and Drug Administration (FDA) is hosting a hybrid public meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds.
FDA Drugs · Jun 8, 2026
2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/07/2022
The Food and Drug Administration (FDA or the Agency) is announcing its 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.”
FDA Drugs · Jun 8, 2026
BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process.
FDA Drugs · Jun 8, 2026
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments | 2021 - 06/28/2021
This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II.
FDA Drugs · Jun 8, 2026
FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology - 07/28/2026
The US. Food and Drug Administration (FDA) in collaboration with the Health and Environmental Sciences Institute (HESI), and the Safety Pharmacology Society (SPS) will host a hybrid public workshop entitled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026.
FDA Drugs · Jun 8, 2026
Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight
The agency continues to prioritize the speed and efficiency with which generic drugs are regulated, while balancing the need for minimizing risk and ensuring access to quality medications.
FDA Drugs · Jun 8, 2026
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
FDA Drugs · Jun 8, 2026
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - 06/08/2026
This workshop provides an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Learn more.
FDA Drugs · Jun 8, 2026
Approved Drugs: Questions and Answers
How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?
FDA Drugs · Jun 8, 2026
Generic Drugs: Questions & Answers
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
FDA Drugs · Jun 8, 2026
CDER Leadership Bios
CDER Leadership Bios
FDA Drugs · Jun 8, 2026
Over-The-Counter Monograph Drug User Fee Program (OMUFA)
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.