Upstate Pharmacist Sentenced for Unlawfully Compounding Radioactive Drugs
FDA-OCI, Greenville, South Carolina, Richard A. Sheriff, Shertech, Technescan, MAG3
July 26, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: July 26, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Premier Manufacturing Products, LLC - 678912 - 07/02/2024
Finished Pharmaceuticals/Unapproved New Drug
Proposed Approach to Regulation of Cellular and Tissue-Based Products
Proposed Approach to Regulation of Cellular and Tissue-Based Products
FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products
FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to compounded semaglutide dosing errors. Errors resulted from patients measuring and se
Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products - 10/03/2024
At this workshop, we will convene experts to share insights on product-specific guidance (PSG) development, research initiatives, bioequivalence and quality considerations, as well as case studies fro
Ranier’s Compounding Laboratory. Jeannette, PA. 483 issued 02/13/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 02/13/2024 Short Title (70 char) Ranier’s Compounding Laboratory. Jeannette, PA. 483 issued 02/13/2024 FEI Number 30
Carie Boyd Pharmaceuticals. Irving, TX. 483 issued 06/21/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 06/21/2024 Short Title (70 char) Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma. Orlando, FL. 483
Hikma Injectables USA Inc. Dayton, NJ. 483 issued 06/25/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 06/25/2024 Short Title (70 char) Hikma Injectables USA Inc. Dayton, NJ. 483 issued 06/25/2024 FEI Number 3022897129
M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Brassica Pharma Pvt Ltd. 1/19/2024
Brassica Pharma Pvt Ltd. 1/19/2024. Country: India. Record Type: 483
Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Biocon Biosphere Limited - 6/14/2024
Biocon Biosphere Limited - 6/14/2024. Country: India. Record Type: 483
Container Closure System and Component Changes: Glass Vials and Stoppers
Container Closure System and Component Changes: Glass Vials and Stoppers
Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label
East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSA
Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label
East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSA
Patents and Exclusivities for Generic Drug Products
The FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book,” includes information about patents or exclusivities that apply to a pa
July 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: July 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.