Update on FDA’s Aggressive, New Enforcement Policies | Sheldon Bradshaw | 2011| Archived Recording

Update on FDA’s Aggressive, New Enforcement Policies | Sheldon Bradshaw | 2011| Archived Recording

October 21st, 2013 // 5:29 pm @

Archived Recording – CD and download available!

FDA is now strongly committed to more and stronger FDA enforcement. Learn how new FDA leaders are increasing enforcement actions.

What You Will Learn in This FDA Enforcement Update:

FDA is getting more aggressive in the following ways:

    • Set post-inspection deadlines.  FDA will give regulated industry no more than 15 business days to respond to inspectional findings before the agency issues a warning letter or takes other enforcement action.Speed up the warning letter process.  FDA will limit review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
    • Work more closely with regulatory partners.  When public health is at risk, FDA will coordinate with its local, state, and international regulatory partners to take rapid action.Prioritize follow-up on warning letters and other enforcement actions.  FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
    • Respond to public health risks immediately.  FDA will act quickly and aggressively to deal with significant public health concerns and violations.
    • Implement a warning letter “close-out” process.  If a firm fully corrects violations raised in a warning letter, FDA will issue an official “close-out” notice and post this information on the FDA Web site.

FDA has judicial, administrative, and informal remedies to protect the public from dangerous and illegal products, to punish persons and companies who violate the law, and to deter violations.

More covered in this Webinar:

I.Judicial remedies include seizures, injunctions, criminal prosecutions, and certain civil money penalties.

II.Administrative remedies include civil money penalties, product recalls, warning letters, debarment, and withdrawals of product approvals.

III.FDA also has other tools to promote compliance, e.g., publicity, cooperation with other governmental entities, including the states.

Also get the latest update on recent enforcement actions, prosecutions, civil money penalties, administrative penalties, recalls and warning letters.

About the Presenter:

In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as a partner and co-chair of the firm’s Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers – on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA’s jurisdiction. At the firm, Mr. Bradshaw advises clients in the same areas in which he worked while Chief Counsel of FDA.





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