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The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
The FDA cited a Chinese drug and API facility for a slew of violations of agency standards, based on an inspection of the company’s plant in Tianmen. Read More
Shortly after taking office in January, President Trump issued an executive order directing agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs exceeding benefits — and now the FDA is asking the public for suggestions. Read More
Sens. Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R-W.Va.) urged FDA Commissioner Scott Gottlieb to task the agency’s opioid policy steering committee with promoting “partial fill” policies to limit the number of unused pills in circulation. Read More
The committee’s report will assess the quality, safety and efficacy of the product, as well as examine the risk-benefit balance based on intended populations and markets. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More
Biocon said it plans to re-submit applications for European approval of two cancer-treatment biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. The company said it intends to fix the problems by Sept. 30. Read More
The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Read More