Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Companies gaining access to Ozempic, making compounded drugs: What to know

Companies that make compounded drugs obtain semaglutide API from authorized and registered chemical manufacturers.
RAPS

FDA Kicks off Generic Drug User Fee Reauthorization Process

Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun. In a Federal Register notice on 21 April ...
RAPS

New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...