FDA Related News

Human Drugs

PDSA Joins Opposition to Florida Drug Importation Program

The Pharmaceutical Distribution Security Alliance calls on FDA not to authorize Floridas proposal to import drugs from Canada, saying it would be ille...

Medical Devices

FDA and Medical Device Regulations in 2021: Analysis

Attorney Jim Shehan outlines possible FDA 2021 activities involving medical devices.

Medical Devices

Akesis Galaxy RTi Radiosurgery Device Cleared

FDA clears an Akesis 510(k) for the Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system with continuous 360-degree rotational techno...

Human Drugs

Dr. Reddys Hit With Form-483 After API Inspection

A recent inspection at Dr. Reddys Laboratories active pharmaceutical ingredient manufacturing plant in Middleburg, NY cites three observations on a Fo...

Biologics

2 Governors Ask FDA Vaccine Pooling Approval

Govs. Polis and Brown call on FDA to approve Covid vaccine pooling.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Evelyn Lopez-Brignoni and Cannafyl.

Human Drugs

Author Encouraged by Decade of FDA Drug Approvals

A review of FDA drug approvals in the last decade covers 378 novel drugs and 27 biosimilars, with 25% of them for oncology indications.

Human Drugs

Objectionable Clinical Trial Practices at Florida Clinic

FDA warns a Florida doctor about objectionable conditions in the practices conduct of two clinical trials.

Cannafyl Marketing Unapproved Human, Animal CBD Drugs

FDA warns Cannafyl it is marketing unapproved and misbranded new drugs for use in humans and an unapproved new animal drug.

Human Drugs

FDA Tells Acadia that Nuplazid sNDA has Deficiencies

FDA tells Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and ...