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Medical Devices

FDA Least Burdensome Guidance Could Be Worse: Attorney

Attorney Adrienne Lenz says there are several provisions that should appeal to industry in an FDA final guidance on least burdensome approaches.

Human Drugs

Draft CDER Consensus Standard Guidance

FDA issues a draft guidance seeking comment on a proposed CDER program issue a list of recognized voluntary consensus standards related to drug qualit...

Federal Register

Emergency Use Authorization for Ebola Diagnostic

Federal Register notice: FDA issues an Emergency Use Authorization (EUA) for a Chembio Diagnostic Systems in vitro diagnostic device for detecting Ebo...

Human Drugs

Indoco Remedies FDA-483

FDA releases an FDA-483 with six observations issued following an inspection at Indias Indoco Remedies.

Federal Register

Regulatory Review Period for MSD Italias Zejula

Federal Register notice: FDA determines the regulatory review period for MSD Italias Zejula (niraparib).

Medical Devices

LC Medical Concepts Warned on Wound Kit Manufacturing

FDA sends LC Medical Concepts a Warning Letter after an inspection of the firms Rochester, NY, medical device operations found GMP concerns with the m...

Human Drugs

CGMP Violations at Akorn Decatur Plant

FDA warns Akorn about CGMP violations at its Decatur, IL, drug manufacturing facility.

Federal Register

Comments Sought on Safety Labeling Info Collection Extension

Federal Register notice: FDA seeks comments on an information collection extension entitled Safety Labeling Changes Implementation of Section 505(o)(...

Federal Register

Regulatory Review Period for Newrons Xadago

Federal Register notice: FDA determines the regulatory review period for Newron Pharmaceuticals Xadago (safinamide mesylate).

Federal Register

Info Collection on Assessment of Combination Product Reviews

Federal Register notice: FDA sends to OMB a new information collection entitled Assessment of Combination Product Review Practices.