Tag Archives: Food

FDA Announces Plans to Reform 510(k) Process

On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.… Continue Reading

510(k) Medical Device Review Process Reforms

FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011 including streamlining the "de novo" review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and "establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making." Undoubtedly there will be much more on this in the coming weeks and months.… Continue Reading

Ninth Circuit Court of Appeals Holds that the FDCA Precludes Plaintiff’s Claim Under the Lanham Act

The Ninth Circuit recently confronted an issue of first impression: whether a plaintiff could maintain an action under the false advertising prong of the Lanham Act, where a determination of the alleged falsity would require the court to impinge on the exclusive purview of the Food and Drug Administration (FDA) in deciding whether there has been a violation of the Food, Drug, and Cosmetic Act (FDCA). Although limited to the particular circumstances presented, the opinion reaffirmed the exclusive authority of the FDA to enforce the provisions of the FDCA, and indicates that a plaintiff may not maintain a lawsuit premised on the allegation of a violation of the FDCA, where the FDA itself has not acted.… Continue Reading

Prescription Drug and Medical Device Promotion – New FDA Draft Guidance on Presenting Risk Information

On May 27, 2009, the Food and Drug Administration ("FDA") announced the availability of a draft guidance titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion" ("Draft Guidance"). The Draft Guidance sets forth the standards FDA intends to consider when evaluating promotional pieces to determine whether they effectively communicate risk information in a non-misleading manner. Under the Food, Drug & Cosmetic Act ("FDCA") and FDA's implementing regulations, promotional materials making claims about a product are deemed misleading if they fail to disclose certain information about the product's risks. FDA is accepting comments on the draft through Aug. 25, 2009. Reed Smith's full alert provides a brief outline of the Draft Guidance and identifies issues for possible comment to FDA.… Continue Reading

Commentary: FDA’s New Good Reprint Practice Rule

Recent posts on www.lifescienceslegalupdate.com include: "Commentary: FDA's New Good Reprint Practice Rule". The Food and Drug Administration's new Good Reprint Practice ("GRP") Guidance went into effect January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act. https://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/commentary-fdas-new-good-reprint-practice-rule/ ...and "Dept. of Bad Ideas: Criminalization of Product Liability" regarding the 2006 proposal by Senator Arlen Specter (R.-PA) to criminalize aspects of product liability law. https://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/dept-of-bad-ideas-criminalization-of-product-liability/… Continue Reading