Allowing for post-market monitoring would incentivize sponsors to consider switches and generate data that could inform a decision about potential conditions for safe use “without applying potentially burdensome – and possibly unnecessary – conditions upfront,” Pinney Associates health care consultancy says.
Pinney Associates recommends FDA allow post-marketing surveillance as a condition of safe use for innovative switches rather than requiring all questions about a product’s suitability for nonprescription use be resolved pre-market.
“Not only would allowing for post-market monitoring incentivize more sponsors to consider requesting Rx to OTC switches, but it would...
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.
