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A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards. Read More
The committee members are pressing the FDA to expand the warnings on extended-release opioids to include immediate-release versions of the painkillers. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
Merck and Samsung Bioepis said Wednesday that their biosimilars for Enbrel and Remicade both met primary endpoints in pivotal Phase 3 clinical trials, putting them on the path to filing regulatory submissions. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More