Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment

CGMP/Finished Pharmaceuticals/Adulterated