Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters

FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’

• Source: Shutterstock

US FDA Commissioner Robert Califf offered a preview of what is likely to be the rationale for authorizing the reformulated, bivalent versions of the COVID vaccine that are now pending before the agency.

“As we enter the fall, the FDA has been preparing for how best to protect the public from ongoing and...

More from Vaccines

More from Pink Sheet

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By 

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.