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The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
Generic drug giant Teva received FDA clearance May 30 to market exclusive versions of Pfizer’s blockbuster arthritis pain drug Celebrex (celecoxib) in the 100 mg, 200 mg and 400 mg capsule forms. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More
The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
Australia’s Therapeutic Goods Administration has set a September deadline for companies to adopt a common technical document format for over-the-counter drug submissions. Read More
Generic drugmakers in the U.S. and EU are calling on regulators to create uniform approval pathways for biosimilars and generic medicines, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis so that patients can get them sooner. Read More