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China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A new analysis of opioid availability in 104 countries suggests regulators in emerging markets increasingly important to industry are hindering sales of opioid painkillers to cancer patients. Read More
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
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