How Generic Advances Public Health by Improving Access to Affordable Medication Access to affordable medicines remains a significant public health priority for FDA. The agency regularly […]

What is FDA posting? The following reports list potential signals of serious risks/new safety information that were identified using the FAERS database during the indicated quarter. […]

The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug […]

Report issues to FDA Visit FDA’s statement on tirzepatide Understanding unapproved versions of these drugs   FDA is aware that some patients and health care professionals may […]

[10/02/2024] The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has […]

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Ryuji Hirooka Recipient Title President and Director World Nutrition, Inc. 9449 N 90th Street Ste […]

[10-2-2024] FDA continues to advise consumers not to purchase or use Body Shape Weight Loss System, a product promoted and sold for weight loss. This product […]

Compounding drugs when the drug is in shortage FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded […]

The table below lists all the documents and supportive files applicable to eCTD submissions to CDER and CBER. Version History Submission Standards for eCTD v4.0 Validation […]