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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
…the device, then FDA imputes the new intended use to all shipped units, even if their labeling complies with the existing clearance or approval. According to FDA, the device is…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…section also increases the maximum salary of the members to now not exceed the amount of annual compensation of the President (currently $400,000 per year). The section also directs GAO…
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
…settlement discussions that culminated over six months later. The Proposed Settlement Order filed in the court follows and indeed adopts the court’s key determinations in the August 7 Order. The…
FDA Issues Final Hatch-Waxman Regulations to Implement Some of the Provisions of the 2003 Medicare Modernization Act
…FDA) of the changes compared to the Proposed Rule (including references to the relevant section in the Final Rule). Also, we’ve put together a 100-page Regulation-by-Regulation Redline of the new regulations…
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
…a relationship between the change in the use of the drug product supported by the supplement and the scope of the exclusivity that the supplement earns. The regulation provides that…
Need Some Holiday Reading? Recent FDA Scholarship Worth a Spin
…also require these companies to share with these same competitors the use and distribution arrangements they developed to manage the risks of the products. Supporters describe the bill as the…
FDA Issues Letter Decision on Generic SUBOXONE 180-Day Exclusivity; It’s a Doozy!
…Inc.’s SUBOXONE (buprenorphine and naloxone) Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg (approved under NDA 022410); specifically Dr. Reddy’s Laboratories, Inc. ANDA…
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…20, 2022. The program was set to expire December 31, 2016. This section also removed the mandate for a GAO report on the effectiveness of the program at incentivizing the…
A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion
…the safety or effectiveness of the drug” that is identified after the trial has begun. FDCA § 505(b)(5)(C). Similar to the Company’s approach with the initial indication, Amarin designed a…
CDRH Releases Preliminary Reports with Recommendations for 510(k) Program
…the 510(k) process, facilitate the submission of high-quality device information, or even enhance the agency’s control over unreported device modifications. There is also a risk that CDRH will use the…
The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments
…as part of a pre-sNDA or pre-sBLA meeting). If FDA accepts the application, the sponsor can then submit their supplement in two parts. The sponsor then gets the review ball…
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
…of the standards the Agency has used in practice over the years between the enactment of PDUFA I and PDUFA IV. The statute provides for waivers of, reductions in, exemptions…
Trump Administration Slaps Pharma Industry with International Reference Pricing Rule (But will it Survive?)
…the rule. Finally, President-Elect Biden will take office before the 60-day comment period for the rule expires, and the incoming administration may change or withdraw the rule in the infancy…