id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-022039-y0l943xg	Gruber, Marion F.	Regulation and Testing of Vaccines	2017-07-17		.txt	text/plain	14882	585	34	Section 901 of Title IX of the FDAAA authorizes the FDA to require certain postmarketing studies and clinical trials for prescription drug and biological products approved under the FDA should take action in response to such reports and whether the current pharmacovigilance plan is adequate. Critical information to be contained in the BLA include data derived from nonclinical laboratory and clinical studies that demonstrate that the manufactured product meets prescribed requirements for safety, purity, and potency. Following completion of IND studies demonstrating the safety and efficacy of the vaccine for a specific use and population the sponsor can submit a BLA to obtain a license for a new vaccine under section 351 of the PHS Act for commercial manufacture and distribution of the product.	./cache/cord-022039-y0l943xg.txt	./txt/cord-022039-y0l943xg.txt