Chemistry, manufacturing, and controls information in NDAs and ANDAs, supplements, annual reports, and other regulatory filings.
Advice to the pharmaceutical industry regarding the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be found in the pertinent statutes, regulations, and guidances. The primary statute is the Federal Food, Drug and Cosmetic Act (the Act); applicable regulations appear in 21 CFR 312 and 314. Neither the Act nor the regulations provide sufficient detail on the information that should be included in these submissions. Over the past 14 years CDER has issued a series of guidelines and guidances that provide specific detail related to the recommended filing mechanisms and information that CDER expects applicants to provide. Some of these guidances are applicable to original submissions and some are applicable to post-approval changes. This article will provide an overview of The Act, the pertinent regulations, and the pre- and post-approval guidances.
Sheinin
Eric
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United States Pharmacopeial Convention, Inc., Rockville, Maryland 20852, USA. es@usp.org
Williams
Roger
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D000847:Annual Reports as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards