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A federal judge granted Shire’s motion to dismiss a Federal Trade Commission action against its citizen petitions relating to potential generic competitors, saying the FTC had not met a prerequisite for bringing the lawsuit. Read More
The Council on Radionuclides and Radiopharmaceuticals sued HHS arguing it improperly interpreted the 2016 Medicaid rebate program final rule by applying it to radiopharmaceutical products. Read More
FDA Commissioner Scott Gottlieb highlighted the need to improve international mail facility operations and market conversion to opioids with abuse deterrents Wednesday at a House Energy and Commerce Committee subcommittee hearing on the opioid crisis. Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Read More
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on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program.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