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The House passed an omnibus spending bill Thursday that boosts FDA funding by $135 million for fiscal 2018 for a total of $2.9 billion in discretionary spending. Read More
The council said the inclusion of radiopharmaceuticals is a major burden for radiopharmaceutical manufacturers who must enter a rebate deal with the Centers for Medicare and Medicaid Services in order to receive Medicaid reimbursements. Read More
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on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program.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