FDA Related News

Human Drugs

Vanda sNDA Deficiencies Preclude Certain Reviews: FDA

Vanda Pharmaceuticals receives FDA notification about undisclosed sNDA deficiencies with a supplemental NDA for Hetlioz (tasimelteon) for treating jet...

Human Drugs

Study Finds 1st Digital Med was Approved on Weak Data

A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of Otsuka Pharmaceuticals NDA for mental disorder-treating...

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 7/19/2019.

Federal Register

Accredited Persons Inspection Program Info Collection

Federal Register notice: FDA sends to OMB an information collection extension for its device accredited persons inspection program.

Federal Register

FDA Adopts Geopolitical Naming/Coding Standard

Federal Register notice: FDA announces that it will adopt the current version of the Geopolitical Entities, Names, and Codes (GENC) Standard on 12/17/...

FDA to Study Physician Perceptions in Drug Marketing

CDERs Office of Prescription Drug Promotion (OPDP) proposes research to determine how physician perceptions are influenced by drug marketing.

Human Drugs

Celgenes Otezla Approved for Oral Ulcers

FDA approves a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with Behcets Disease.

Human Drugs

Guide on Next-Gen Sequencing Data for Antivirals

FDA releases a final guidance on submitting next generation sequencing data to the Division of Antiviral Products.

Medical Devices

FDA Clears Erchonia Laser for Musculoskeletal Pain

FDA clears an Erchonia 510(k) to market FX low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.