US FDA Set To Begin Training Patent Examiners This Spring
Prompted by an Executive Order on drug price competition, the cross-agency training aims to ensure that the Patent and Trademark Office is aware of all information that FDA makes available.
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UPDATED: US FDA Has People Working At CMS To Help Implement Inflation Reduction Act
The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem
As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.
Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.