Simplifying Global Compliance
Finger-pointing abounded Tuesday in a Senate hearing on prescription drugs prices, where branded and generic drug industry representatives testified alongside pharmacist, wholesale distributor and benefit manager groups. Read More
Health Canada has proposed fee hikes for reviewing applications for approval of new drugs, for oversight of drug manufacturing facilities, for postmarket monitoring of drug sales and for other regulatory activity. Read More
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft, which were due last week. Read More
A Colorado dietary supplement manufacturer wrongfully included potentially harmful ephedrine alkaloids in one of its products and made improper claims for drug-like effects from others, the FDA said in a warning letter. Read More
The FDA cited a Vital Laboratories facility in Gujarat, India over failure to investigate out of specification results, conditions for material storage, and employee training. Read More
Copyright ©2017. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing