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Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program. Read More
More U.S. states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the Pew Charitable Trusts. Read More
The EMA’s Committee for Medicinal Products for Human Use adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development. Read More
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two EU proposals the groups say could hurt patent rights. Read More
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes final, according to some drug developers and patient advocacy groups. Read More
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold procedures, CFR citations and timelines for agency responses to sponsors. The new version also narrows its focus by omitting references to general IND review procedures included in the previous version that took effect in May 1998. Read More
Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the FDA on standardized formatting for BIMO inspection submissions. Read More
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
Lead sponsor Rep. Bob Latta (R-Ohio) said the bill would “provide more certainty for manufacturers, ensure consumer confidence, and foster innovation.” Read More