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The company said it continues to believe the drug-device combination “could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission.” Read More
The FDA released its BsUFA II fees for FY 2019, lowering biological product development fees from the fiscal 2018 rates while leaving application and program fees unchanged. Read More
The House Energy & Commerce Committee has called on the Federal Trade Commission to “closely analyze” recent mergers by pharmacy benefit managers to assess the impact on prescription drug prices. Read More
For all NDAs containing already approved active moieties, CDER’s pharmacology/toxicology reviewer must check the established pharmacologic class text phrases proposed for the product’s “indications and usage” section. Read More
The PMRS claimed that the FDA’s decision to approve opioid drugs for treating chronic pain without adequate evidence of efficacy is the driving factor behind the opioid epidemic. Read More
“It defies logic that the federal government is not using its enormous purchasing power to get a better deal for seniors on prescription drugs,” said Rep. Peter Welch (D-Ver.). Read More