Final guidance on drug sponsors’ responsibilities for financial disclosures related to clinical investigators who participate revises definitions of due diligence and covered clinical studies from the draft published in 2011, but retains FDA’s statement that it may include such disclosures in the documents released upon product approval for marketing.
FDA’s final guidance on disclosure of potential financial conflicts of interest by clinical investigators offers sponsors some more details on how to fulfill the agency’s requests, but the document retains two serious consequences related to the disclosure process – FDA can refuse to file applications without proper disclosures, and the data itself could be released when the agency approves the drug.
The agency said the final guidance
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.
The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
