USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency...
Canada – Notice – Implementation of ICH E19: A selective approach to safety data...
Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
Two major pharmaceutical industry groups opposed the US Food and Drug Administration’s (FDA) proposal to remove details about interchangeability from product labels in its...
USA – Industry groups seek changes to FDA’s remote interactive evaluation guidance
Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration’s (FDA) approach for conducting remote interactive evaluations (RIE)...
USA – Industry requests more information from FDA on dosage and administration labeling
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
