Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.
House Energy and Commerce Committee support for legislation to overhaul FDA's OTC monograph drug process is unanimous even though the same can't be said for the bill's proposed 18-month exclusivity period for some products approved under the revised program.
Some Democratic members of the committee question the length of the proposed exclusivity period while others oppose any new exclusivity...
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
