Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. - 659854 - 08/14/2024
CGMP/Finished Pharmaceuticals/Adulterated
2024 Meeting Materials, Pharmacy Compounding Advisory Committee
2024 Meeting Materials, Pharmacy Compounding Advisory Committee
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room.
December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products - 10/07/2024
The purpose of this workshop is to engage stakeholders industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for propos
Medical products for rare diseases and conditions
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/dis
FDA Roundup: August 30, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants
FDA authorized for emergency use Novavax COVID-19 Vaccine (2024-2025 Formula) to more closely target currently circulating variants to provide better protection against serious consequences of COVID-19.
Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma. Orlando, FL. State Referral Letter issued 08/13/2024
Task Description Request Please post to the Compounding Inspections Web Page Record Date 08/13/2024 Short Title (70 char) Jubilant DraxImage Radiopharmacies Inc. Orlando, FL. State Referral Letter iss
Maag Prescription Center LLC. Pocatello, ID. Untitled Letter issued 10/01/2020
Task Description Request Please post to the Compounding Inspections Web Page Record Date 10/01/2020 Short Title (70 char) Maag Prescription Center LLC. Pocatello, ID. Untitled Letter issued 10/01/2020
Second Tokushima Factory, Otsuka Pharmaceutical Co. Ltd., Tokushima, Japan 3/22/24
Second Tokushima Factory, Otsuka Pharmaceutical Co. Ltd., 3/22/24 Tokushima, Japan 483
August 30, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Issues Final Rule Increasing the Minimum Age for Certain Restrictions on Tobacco Sales
FDA announced a final rule that raises the minimum age for certain restrictions on tobacco product sales.
August 29, 2024
FDA announced a final rule that raises the minimum age for certain restrictions on tobacco product sales.
AnuMed International, LLC - 674310 - 08/20/2024
Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded
Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. - 676984 - 06/28/2024
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Letter of Support (LOS)
This is a letter issued to a requester that briefly describes CDER’s thoughts on the potential value of a biomarker and encourages further evaluation. This LOS does not imply qualification of a biomar
FDA Roundup: August 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes
FDA expands indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and ol
FDA Roundup: August 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Global Calcium Private Limited, 8/2/2024
Global Calcium Private Limited, 8/2/2024 Country: India Record Type: 483