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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
A bipartisan group of members of the House Energy and Commerce Committee introduced new legislation to reform the FDA’s monograph system for over-the-counter ingredients and replace the agency’s rulemaking process for approving OTCs with a system based on administrative orders. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
The agency includes complete summaries of study results, protocols and protocol amendments and statistical plans for all pivotal studies supporting the approval. Read More