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The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint regulatory agency with Australia. Read More
The FDA’s proposal to survey pharmacists and patients on how changes to the physical appearance of a therapy may affect patient perceptions and drug adherence is raising concerns among both brand and generic drug manufacturers. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized yesterday. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized yesterday. Read More
The FDA wants manufacturers to stop sending paper prescribing information to pharmacists and physicians who often don’t read it and only submit it electronically to the agency, a move that would create a single source for accurate labeling that would always be up to date. Read More
Teva’s first-filer rights to generic Celebrex are in doubt after a federal appeals court struck down a lower court’s decision upholding an FDA finding that the Israeli drugmaker was entitled to exclusivity on the blockbuster arthritis therapy. Read More