FDA Invites Stakeholders To Join GDUFA III Talks Virtually
Dan Leonard Has Taken Helm Of AAM Just Ahead Of User Fee Negotiations
The FDA has called on public stakeholders to notify the agency of their participation in the next Generic Drug User Fee Amendments program, as it sets the agenda for improving the generic drug approval process, including for complex generics.
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Dan Leonard’s communications background, in addition to his policy expertise, may prove useful for the Association for Accessible Medicines as it navigates ongoing market and public policy challenges.
Teva has completed its portfolio of digital inhalers by launching a further two products, AirDuo Digihaler (fluticasone propionate/salmeterol) and ArmonAir Digihaler (fluticasone propionate), in the US. The pair join the firm’s previously launched ProAir Digihaler (albuterol sulfate).
Dr Reddy’s has announced the launch of its OTC versions of Pataday olopatadine solution in the US. The firm’s entry into the OTC eyecare space follows other OTC launches of rivals to Voltaren and Nicorette earlier this year.