CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.
FDA is willing to listen to everyone affected by its decisions, but patient advocacy groups may get special recognition. That is the message Center for Drugs Evaluation and Research Director Janet Woodcock conveyed at the Partnering for Cures meeting in New York.
“We need to hear from the affected community what type of [drug side effect] tradeoffs they think are acceptable and...
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.
