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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
The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Read More
AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Read More
CDER Director Janet Woodcock Friday announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics. Read More
The expert group called for more data, possible further trials and a clearer distinction between COPD and asthma before they could endorse the drug’s efficacy. Read More