Regulatory Roundup: FDA Calling on Industry to Provide Feedback on Existing Regulations

May 05, 2011

By PharmTech Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document FDA announced on its Transparency Blog last week that it is calling on industry to provide feedback on existing regulations and whether any of them need improvement. The initiative is based on an executive order from President Obama issued this past January to improve regulation and regulatory review. Industry can provide comments through the Federal eRulemaking Portal.

Outsourcing

EMA Recommends Suspension of 700 Drugs Tested at GVK Site

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions.

Baxter BioPharma Solutions Joins PBOA

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.

Fill/Finish Capacity Use for Biologics

There are significant differences between small molecules and biologics fill/finish capacity.

|More|

	Outsourcing Outlook Eric LangerYear in Review: Trends in Biopharma Manufacturing Outsourcing
	Ingredients Insider Cynthia ChallenerFDA Approves Novel Treatments in 2014
	Regulatory Watch Jill WechslerFDA Realigns Drug Inspection and Manufacturing Oversight
	Ask The ExpertSiegfried Schmitt Good Distribution Practices: Who is Responsible?

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