FDA Related News

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...

Human Drugs

FDA Doing Better On Sex, Gender Differences in Drug Development: Study

Nine FDAers say FDA is doing better accounting for sex and gender differences in drug development.

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.

Biologics

2 Governors Ask FDA Vaccine Pooling Approval

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

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 ...

Medical Devices

FDA Issues Section 506J Notification Obligation Table

FDA issues a table with recommendations for medical device manufacturers to use in association with an earlier pandemic guidance on notifying the agen...