By Ramsey Baghdadi
In February, during a Congressional hearing focusing on the Food & Drug Administration’s approval of Sanofi-Aventis ’ antibiotic Ketek, a panel of ex-FDA witnesses did not have many good things...
FDA's Temple of Wisdom: The Dean of Drug Development
FDA will have new money and new authority before the year is out. But translating the new drug safety reforms into practice will be the responsibility of some old hands, including the Robert Temple, the dean of FDA's drug review group. The question drug companies should have: What is he thinking?
More from Platform Technologies
• By
Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA
• By
The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.
• By
mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.
• By
Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.
More from Advanced Technologies
• By
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
• By
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
• By
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.