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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
European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations. Read More
The FDA has unveiled the 14 members of its reconstituted Pharmacy Compounding Advisory Committee, a group that will play an influential role in deciding which products will be prohibited from compounding under a 2013 law. Read More