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At least 75 percent of clinical trials are extended by six weeks or more because of failure to enroll enough patients, a new study finds, but help may be on the way in the form of “big data.” Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
State governments are continuing their push to regulate compounding pharmacies, placing tighter restrictions on those compounders who stay out from under the voluntary regulations imposed by the Drug Quality and Security Act. 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
With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. 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
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
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