That did not take long. As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees. Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened? Well, …
Menu
Deborah L. Livornese
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the TableJanuary 11th, 2021
- GAO Report on Over-the-Counter DrugsAugust 10th, 2020
Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs. In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020. The report focuses on …
- FDA Updates Guidance on Conducting Clinical Trials During COVID-19 Emergency to Reflect Real World ChallengesJuly 10th, 2020
Back in the Spring, one of the first COVID-related guidances FDA issued was on the conduct of clinical trials during the COVID-19 emergency. This guidance was updated with a Q & A section just a week later (see our blog posts here and here) and …
- No Signature Required: FDA Provides Temporary Relief from Obligation to Obtain Physical Signatures for Prescription Drug SamplesJune 15th, 2020
The Prescription Drug Marketing Act (PDMA) and implementing regulations establish procedures for distributing prescription drug samples, including requirements related to requests, receipts, and recordkeeping. Federal Food, Drug, and Cosmetic Act § 503(d); 21 C.F.R. Part 203. Typically, many drug manufacturers that use drug samples as …
- FDA Clarifies Institutional Review Board Requirements for Reviewing Individual Access Requests for COVID-19 DrugsJune 9th, 2020
FDA issued another COVID-related guidance for immediate implementation last week. Citing a substantial increase in the number of requests for individual patient expanded access requests for COVID-19 investigational drugs (which we will use here to include biological products), on June 2, 2020, FDA released a …
- New COVID-19 Guidances for Drugs and Biologics: FDA Provides Further Clarity on the Pre-IND Process and Clinical Trial ExpectationsMay 29th, 2020
Two new guidances, both issued by FDA on May 11, 2020, focus on drugs and biological products proposed for use against COVID-19. The first is entitled COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (the “Pre-IND …
- OTC Monograph Reform Becomes Law; HP&M Issues Summary and AnalysisApril 8th, 2020
Amidst the onslaught of regulatory and legislative announcements and changes occurring daily during this unprecedented time, a long-awaited (in some quarters) legislative change quietly and finally became law. On March 27, 2020, President Trump signed into law the CARES Act which includes an array of …
- Vanda Isn’t Dropping This Bone Despite Negative Court DecisionFebruary 21st, 2020
Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?” We certainly did (and had previously here and here). You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition …
- The Value of Priority Review Vouchers – GAO’s Two CentsFebruary 11th, 2020
Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …
- Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller GlassDecember 16th, 2019
Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program. FDA generally conducts …
- Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval PromotionNovember 25th, 2019
Just as many object to holiday music in November, the Office of Prescription Drug Promotion (“OPDP”) objected in an untitled letter issued earlier this month to claims made for an investigational drug. The statements (since removed) appeared on a company website about an investigational drug …
- Gene Therapy Company Sues FDA After Being Placed on Clinical HoldNovember 11th, 2019
On November 7, 2019, gene therapy company Regenxbio Inc., filed suit in U.S. District Court in Washington, D.C. against FDA asking the court to set aside a partial clinical hold on one clinical trial and a full clinical trial for another. The complaint also seeks …
- New California Requirement for Some CosmeticsOctober 14th, 2019
On September 20, 2019, the governor of California approved AB 647 which expands the obligations of manufacturers and importers of cosmetics (and disinfectants) containing hazardous substances. Beginning on July 1, 2020, these manufacturers and importers are required to not only provide safety data sheets (“SDSs”) …
- Not Dead Yet – Far from It: OTC Monograph Reform Back on Congress’ RadarJune 27th, 2019
We knew it would be back. It was never dead, though perhaps forgotten by some (never us), but OTC Monograph Reform is back in the public eye again. Lawmakers appear to be taking to heart CDER Director Janet Woodcock’s remarks last week in which she urged …
- Ain’t No Sunscreens When It’s Done (Almost): FDA Issues Proposed Monograph on Sunscreens with Only the Oldies but Goodies Categorized as GRASEFebruary 27th, 2019
Back in 2014, The Sunscreen Innovation Act (“SIA”) amended the Federal Food, Drug, and Cosmetic Act with the goal of accelerating the review of sunscreen ingredients that had been proposed for addition to the sunscreen monograph. Although the original focus of the SIA was on …