USA – FDA updates guidance on reporting manufacturing disruptions for finished products and APIs
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
USA – FDA issues emergency guidance to spur development of monkeypox tests
The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...
USA – FDA announces CMC review pilot for drugs with expedited development
The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program...
USA – FDA finalizes guidance on REMS format and content
The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and...
USA – FDA seeks feedback on artificial intelligence in drug manufacturing
The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
USA – FDA approves first drug to delay onset of type 1 diabetes
The company submitted positive results from the randomised, double-blind, placebo-controlled TN-10 trial that included 76 patients with stage 2 type 1 diabetes.
Results showed that,...
