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The FDA, showing no signs of easing its advertising and marketing enforcement, has rapped DARA BioSciences for omitting risk information about its cancer drug Soltamox in a sales aid. Read More
HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), removing the office out from under the Office of Pharmaceutical Quality. Read More
India’s Parliamentary Standing Committee on Health and Family Welfare is taking the next step in its effort to regulate the more than 5,000 unapproved fixed dose combination (FDC) products on the market in the country, calling for recommendations from technical experts. Read More
The European Commission is launching a pilot program to help drugmakers avoid last-minute conflicts with health technology assessors as they are bringing products to market. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
The FDA has rejected Sanofi’s plans for an expanded indication in relapsing multiple sclerosis for its drug Lemtrada, the second pipeline setback for the company since November. Read More
India’s drug regulators are drafting new rules that would classify drugs with new formulations and delivery mechanics as “new drugs” — a move that would require drugmakers to conduct additional trials before selling the products. Read More
The FDA has lifted a partial clinical hold on Cell Therapeutics’ blood cancer drug tosedostat, giving the green light for continuing mid-stage clinical trials. Read More
A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More