On Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).
For the past few years, Pharmaceutical Technology has asked its readers what they think is in store for the pharmaceutical industry for the coming year. Read more »
FDA is close to receiving the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well. Read more »
After rejecting two obesity-drug candidates in recent months, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended two weeks ago that the agency approve a third drug, Contrave (naltrexone sustained release [SR]/bupropion SR) by Orexigen Therapeutics (San Diego). Members of the expert panel voted 13–7 to approve the drug, but recommended that additional studies be conducted to investigate potential heart risks. Read more »
China said it will work to crack down on counterfeit products such as software, music, organic corn, and pharmaceuticals, according to an article from the Associated Press. The government will launch a six-month campaign focused on eradicating sales of illegally copied and fake goods, said Jiang Zengwei, a deputy commerce minister, at a news conference earlier this week. Read more »
The wait for the release of a new weight-loss drug got longer recently as regulatory decisions were not in favor of fat-fighting treatments. The US Food and Drug Administration decided in October not to approve two anti-obesity treatments, sending complete response letters (CRLs) to the drugs’ sponsors. Read more »
Improving drug quality and combating the threat of counterfeit and substandard medications were the goals of recent efforts by regulators and leaders across Africa, where fake drugs are a particularly serious problem. Read more »