GPhA and other stakeholders may propose changes to the GDUFA user fee structure amid small business complaints about burden of facility fees.
FDA has been using pieces of the PDUFA application management structure to build the generic drug user fee program. Now, the generic industry may request a payment structure change to make GDUFA more closely resemble its older sister.
A change either to accommodate calls for a small business waiver or alleviate some of the burden imposed by facility...
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.
