Camargo

OCTOBER 14, 2021

The new Type D meeting , which allows for quicker discussion of a narrow set of issues (no more than two focused topics) between the FDA and a sponsor, such as a follow-up question that raises a new issue after a formal meeting. Continued development of the use of complex innovative trial designs. Container-closure changes.

Development 189

Development Packaging Packaging Generic Drugs 189

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.

Drugs 71

Drugs Manufacturing Medicine Compliance 71