The fda is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices Approval information by product type drugs human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) drug approval reports by. The drug establishments current registration site is a publication of currently registered establishments which manufacture, prepare, propagate, compound or process drugs that are distributed in. Drug shortages find information about drug shortages caused by manufacturing and. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998 Novel drugs are new drugs never before approved or marketed in the u.s
See drugs@fda for information about all of cder’s approved drugs and biological products Premarket approval (pma) is the fda process of scientific and regulatory review to evaluate the safety and effectiveness of class iii medical devices Class iii devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury Biologics products and establishments 9 , where information about vaccines, allergenics, and blood products is available Office of nonprescription products 10 Drugs@fda includes most of the drug products approved since 1939
