Category Archives: FDA

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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

FDA Announces Its Plan For Changes to the 510(k) “Approval” Pathway

By Peter S. Reichertz and Allie Frumin January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; … Continue Reading

E-CIGARETTES GET A “SMOKING” BREAK: D.C. Circuit Clarifies Scope of FDA’s Authority Over E-Cigarettes

By Deborah M. Shelton and Allie Frumin On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred … Continue Reading

FDA Announces Much Anticipated Public Hearing on Biosimilars

By Deborah M. Shelton Having had the opportunity to analyze the biosimilars provisions of the new health care law enacted this past March, stakeholders have at long last the chance on November 2-3 to weigh in on FDA’s implementation of the biosimilar approval pathway. FDA will hold a two-day public hearing on November 2-3, 2010, from … Continue Reading

FCC And FDA Focused On Convergence Of Communications And Medical Systems

By Peter S. Reichertz, Brian D. Weimer and Daniel Brooks 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 … Continue Reading

FDA’s Regulation of Laboratory Developed Tests (LDTs) – Changes on Horizon?

By Deborah M. Shelton For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that … 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?

By Peter Reichertz 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 … Continue Reading

New Taxes for Pharmaceutical and Medical Device Manufacturers/Importers/Distributors

By Peter Reichertz Manufacturers As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration … Continue Reading

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