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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
…of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the…
Proposed Changes to the Device Intended Use Regulation
…or written statements’ that may be weighed as evidence of objective intent. [United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 (W.D. Tex. 2016).] Following the court’s…
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…
The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments
…technology strategy document, by Sept. 30, 2024. 5. Advancing Real-World Evidence (RWE) Program – The 21st Century Cures Act mandated that FDA develop a program for using RWE to support…
What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19
…under the PREP Act. Specifically, the statute defines a “covered countermeasure,” to include “a . . . device . . . authorized for emergency use in accordance with section 564.”…
A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion
…(see Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n , 447 U.S. 557 (1980)) and finding that pharmaceutical speech qualifies for such protection (see Sorrell v. IMS Health,…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…hindsight is 20/20 – the need for LDTs during disease outbreaks had been foreseen in comments to FDA criticizing past FDA efforts to limit LDTs. See, e.g., American Clinical Laboratory…
The Shutdown: An Update on FDA Activities
…none. In a Statement of Administration Policy, the Office of Management and Budget indicated that “[i]f the President were presented with . . . H.J. Res. 77 [and other other…
Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution
…overall survival has not been demonstrated for TAFINLAR in combination with trametinib. 01/09/2014 (01/09/2021) trametinib and dabrafenib (Mekinist And Tafinlar) Treatment of Stage IIb through IV melanoma (9/20/2012) MEKINIST (trametinib)…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…under NDA No. 020698 for the treatment of occasional constipation. FDA subsequently approved several ANDAs for generic versions of prescription MIRALAX. On October 6, 2006, FDA approved NDA No. 022015…
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
…commercial.” Guidance, at 12. Process for Submitting Requests for Waivers, Reductions, and Refunds. The guidance discusses the timing for submitting requests for waivers, reductions, and refunds, as well as the…
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…
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…