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Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…consist of: $18,500,000 for Inspection Modernization and Training; $5,000,000 for the National Integrated Food Safety System; $11,500,000 for Education and Technical Assistance for Industry; $2,500,000 for Technical Staffing and Guidance…
As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
…Initiative Environment, Health, and Safety Research Strategy as updated in October 2011. Office of Cosmetics and Colors– The Committee recommendation includes not less than $11,700,000 for cosmetics activities, including not…
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…of effectiveness. [(60 Fed. Reg. at 10,286, 10,290 (Feb. 23,1995))] . . . and The antitussive directions are 5 to 10 mg every hour as needed, while the anesthetic/analgesic directions…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
Proposed Changes to the Device Intended Use Regulation
…for the evaluation of device performance. There are academic studies, journal articles, disease‑focused societies, symposia, conferences, case studies, clinical guidelines, talks by key opinion leaders, and a host of other…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act, April 17, 2020 as modified on May 19, 2020. Transparency and Communication are…
Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution
…for recurrent or progressive CLL. 01/19/2016 (01/19/2023) oxybate (Xyrem) Treatment of narcolepsy (11/7/1994) Treatment of excessive daytime sleepiness in patients with narcolepsy 11/18/2005 (11/18/2012) oxybate (Xyrem) Treatment of narcolepsy (11/7/1994)…
A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion
…Vascepa for that indication. Subsequently, FDA rescinded the ANCHOR SPA, something FDA has done only 10 times among approximately 1,000 SPAs, and issued a Complete Response Letter to Amarin indicating…
What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19
…is no mechanism to import personal protective equipment for a medical use (Gloves, Gowns, Surgical Apparel, etc.,) that is not in compliance with traditional medical device requirements, even if FDA…
Deliverance: FDA is Sued Over the Applicability of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs; Agency Gets a Short Reprieve to Make a Final Decision
…Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS XR (tacrolimus extended-release tablets), 0.75 mg, 1 mg, and 4 mg, for prophylaxis…
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
…reductions, and refunds. See 76 Fed. Reg. 13629 (Mar. 14, 2011); FDA, Draft Guidance for Industry, User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Mar. 2011, rev….
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
The Shutdown: An Update on FDA Activities
…CBER; some PMA and PDP supplements (e.g., panel-track, 180-day, real-time, 30-day notice); 510(k)s; 513(g)s; annual reports for PMAs, PDPs, and PMRs; and registration information submitted under section 510 by a…
Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Promotion
…v. Pub. Serv. Comm’n, 447 U.S. 557 (1980)) and found that pharmaceutical speech qualifies for such protection (see Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2672 (2011)). August…
FDA Proposes to Clarify and Update Orphan Drug Regulations
By Kurt R. Karst – On October 19, 2011, FDA issued a proposed rule to amend the Agency’s December 29, 1992 (57 Fed. Reg. 62,076) orphan drug regulations. The proposal…