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Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
The FDA and the World Health Organization (WHO) are considering placing new restrictions on 26 popular painkillers, including the widely used generic opioids tramadol and tapentadol. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More
Drugmakers that promote their products in real time on blogs, social media sites and other interactive websites need to submit those sites to the FDA for review as promotions. Read More
The Justice Department recovered about $1.2 billion in drug-related False Claims Act (FCA) settlements and judgments in fiscal 2013, a drop from last year’s total. Read More
When creating product labels for the Canadian market, drugmakers’ claims should be based on the product’s own merits rather than on how it compares to other products, Health Canada says. Read More
Rachel Sherman, CDER’s associate director for medical policy and director of the Office of Medical Policy (OMP), will retire Jan. 25 after serving 25 years at the FDA. Read More
Because nanosized solubilizers known as block copolymer micelles (BCM) contain highly functional polymers, drugmakers that use them are recommended to apply quality-by-design (QbD) principles within a “well-defined manufacturing process” to ensure consistent quality. Read More
Congressional lawmakers will work to eliminate the Physician Payment Sunshine Act requirement that drugmakers disclose gifts of medical journals and textbooks to physicians after the Centers for Medicare & Medicaid Services (CMS) refused their request to reverse the policy. Read More