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Manufacturers submitting stability data in support of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) need to identify the analytical procedures used to generate the data, according to a draft guidance released by the FDA yesterday.
The FDA hopes to determine which scientific and technical issues are the most disputed during current Good Manufacturing Practice (cGMP) and preapproval inspections through a year long pilot project meant to test the agency’s draft formal dispute resolution guidance.
The latest FDA draft guidelines on electronic submissions are likely to cause problems with firms submitting promotional material to the agency's Division of Drug Marketing, Advertising and Communications (DDMAC), the Biotechnology Industry Organization (BIO) told FDA in comments submitted late last month.
Drugmakers should assess the powder mix uniformity of their raw materials and correlate this data with stratified in-process dosage unit data and finished product samples before implementing manufacturing control methods on their products, the FDA recommended in a new draft guidance.
Eli Lilly has resolved FDA concerns about current GMP issues at its Indianapolis facilities, where it plans to manufacture the antidepressant Cymbalta and injectable schizophrenia drug Zyprexa, the company announced recently.
The FDA is cleaning up its guidance documents governing generic drugs policies, announcing that the Office of Generic Drugs was reviewing and withdrawing some of its policy and procedure guides (PPGs).
The FDA is proposing to require manufacturers to submit data from all bioequivalence studies in abbreviated new drug application (ANDA) amendments and supplements to applications.
The FDA has asked drug manufacturers if mandated reporting requirements for manufacturing changes for already approved drugs and biologics are appropriate and not overly burdensome.
The first outside party notified by manufacturers, importers or distributors when the decision to recall is made should be FDA district recall coordinators, not customers or the press, according to a new FDA guidance.
The FDA has revised storage stability testing of new drug substances and products, and products packaged in semipermeable containers, to accommodate climates that have higher humidity, the agency announced in a pair of revised guidances that went into effect in late November.