Tag Archives: Miscellaneous

Comment Period to Close On Petition to FDA for Mandatory Labeling of All Foods Produced Using Genetic Engineering

By Robert Uram On March 27, 2012, the comment period will close on a petition filed by the Center for Food Safety that calls for the FDA to issue new regulations requiring labeling of all foods produced using genetic engineering (GE). Docket No. FDA-2011-P-0723 (Filed October 12, 2011). Unlike many other developed countries – such … Continue Reading

Institute of Medicine Report: Dead on Arrival

By Seth A. Mailhot On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device … Continue Reading

User Fees for Generic Drugs – What are the Issues?

By Peter Reichertz On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment … Continue Reading

FCC And FDA Focused On Convergence Of Communications And Medical Systems

Last week, the Federal Communications Commission ("FCC") and the Food and Drug Administration ("FDA") launched a joint initiative to clarify the approval process and regulatory requirements for converged communications and health care devices. In a two-day joint meeting held on July 26-27, 2010, the two agencies solicited comments from industry representatives "to gain a better understanding … Continue Reading

Elimination of Customs Duties Possible for Over 700 Additional Pharmaceutical Products and Chemical Intermediates

By Peter S. Reichertz By letter dated May 27, 2010, the U.S. Trade Representative (“USTR”) sent a letter to the U.S. International Trade Commission (“ITC”) requesting that the ITC provide information about over 700 pharmaceutical products and chemical intermediates for which the elimination of custom duties may be proposed. As part of the “zero-for-zero” initiative of … Continue Reading

The FDA Transparency Initiative: Another One Way Street?

On May 19, 2010, FDA published on its website a series of proposals designed to promote “openness” and “transparency” in government. The document, entitled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the United States Food and Drug Administration” can be found here.  The document contains 21 specific proposals about changing the Agency’s policies … Continue Reading

Antitrust Division Will Not Challenge Cost Information Exchange Program in California

In a Business Review Letter[1] dated April 26, 2010, the U.S. Department of Justice, Antitrust Division (hereinafter, “the Division”) stated that it would not challenge a data sharing program proposed by three health care associations located in California. From the Division’s vantage point, the program posed little risk of facilitating anticompetitive conduct; rather, the most likely … Continue Reading

FDA Proposed Rule: Sponsors Must Report Suspicions of Falsified Study Data

A proposed FDA rule would require all “sponsors” (defined broadly) to report not only known falsification of study data but also falsifications merely suspected. The rule, “Reporting Information Regarding Falsification of Data,” defines falsification as “creating, altering, recording, or omitting data in such a way that the data does not represent what actually occurred.” The … Continue Reading

Shift in FDA’s Regulation of Products Marketed as Dietary Supplements and Functional Foods?

Manufacturers of liquid supplements and energy drinks appear to be in the FDA crosshairs. On December 3, 2009, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a draft guidance, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” The guidance took many … Continue Reading

FDA’s New Reportable Food Registry Requirements

The Food and Drug Administration (FDA) recently launched its Reportable Food Registry (RFR) electronic portal. In conjunction with this launch, FDA has issued a final guidance further discussing the specific requirements. The RFR requires responsible parties to file a report through the RFR electronic portal at http://rfr.fda.gov when there is a reasonable probability that the use … Continue Reading

OTC Drug and Dietary Supplement Labeling: Adverse Event Reporting Information

Recently, FDA issued its final guidance on the requirements for OTC drugs and dietary supplement labeling to include contact information for consumer reporting of a serious adverse event. This guidance builds upon requirements that were passed into law in the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (“the Act”).  … Continue Reading

Hamburg at the Helm: FDA Commissioner Sets New Enforcement Priorities

With “effective enforcement” and “transparency” as her resounding themes, the new FDA Commissioner, Margaret A. Hamburg, M.D., on August 6th, 2009, introduced herself and the FDA’s priorities to the attendees at a conference sponsored by the Food Drug Law Institute. The Commissioner used this opportunity to emphasize her commitment to “swift, aggressive, and effective enforcement of … Continue Reading

Restaurants, Too?

As the Senate works toward health-care reform legislation, the Senate HELP Committee has released the 615 page bill that Senator Chris Dodd (D-Conn.) will soon introduce on behalf of Senator Edward Kennedy (D-MA), The Affordable Health Choices Act. The Senate’s HELP and Judiciary committees expect to begin the markup process this month. Included with a … Continue Reading

EU Cosmetics Regulation Receives Welcome Facelift

Last month, the European Parliament approved new rules that will increase cosmetic safety and simplify regulatory procedures in the European Union. The legislation, which resulted from a compromise negotiation between Parliament and Council representatives, will take the form of a single regulation that applies to all member states simultaneously, and will replace the patchwork of 27 … Continue Reading

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