Drugindustrydaily

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Oct. 18, 2017

Vol. 16
No. 201

Headlines

Blame Flies at Capitol Hill Hearing on the Reasons for High-Priced Drugs

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

Canadian Drug Regulators Unveil Fee Increases

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

Stakeholders Say FDA Guidance on Post-Approval Changes for Biologics Needs Clarification

The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments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

Green Herb Blackened in FDA Warning Letter

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

FDA Flags Vital Laboratories for Inadequate Storage, Training

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