This Week at FDA: mRNA …
Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative update…
Wound dressing firm war…
An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received…
GDUFA III commitment le…
With the negotiations for the third iteration of the Generic Drug User Fee Amendments (GDUFA III) program complete…
Asia-Pacific Roundup: I…
India has proposed regulatory reforms intended to encourage R&D and innovation in the pharma and medtech industrie…
Nitrosamine detection t…
Pharmaceutical manufacturers should ensure that the analytical tests they are using are “fit for purpose” to ensur…
FDA official: Growing n…
Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and imp…
FDA issued vaccine EUAs…
Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections bef…
FDA launches portal for…
The US Food and Drug Administration (FDA) on Friday launched its new NextGen Portal for reporting manufacturing vo…
FDA authorizes Pfizer C…
The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued,…
Improving transparency …
Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada…
Asia-Pacific Roundup: T…
Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcar…
FDA encourages industry…
An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advance…
