FDA Policy/General
OTC Monograph FY 2025 User Fee Rates
Federal Register notice: FDA is announcing the over-the-counter monograph order request (OMOR) fee rates for fiscal year 2025. They are: * OMOR: Tier 1 — $559,777 * OMOR Tier 2 — $111,955
David McFarland
FDA Policy/General
Info Collection on FDA Quantitative Testing
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The collection supports FDA’s use of quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions to FDA
Drugs
CDER Used AI/ML in Kineret EUA
CDER says it used artificial intelligence/machine learning (AI/ML) in 2022 to identify a suitable patient population for emergency use authorization of Sobi’s Kineret (anakinra), an interleukin-1 inhibitor indicated to treat Covid-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing
Drugs
Zymedi Gets Orphan Status for ZMA001
FDA has granted Zymedi an orphan drug designation for ZMA001, a proposed first-in-class antibody treatment in development for pulmonary arterial hypertension (PAH), an inflammatory vascular disease that the company says is characterized by the remodeling and narrowing of pulmonary arterioles due to various causes. “The infiltration of immune
Drugs
Alert on Megadyne Patient Return Electrodes
FDA and Health Canada are alerting healthcare providers and facilities about the safe use of Megadyne Medical Products’ Mega 2000 and Mega Soft Patient Return Electrodes, which have been at the center for four recalls since 6/2023 over reports of burn injuries in pediatric and adult patients and healthcare
Drugs
Ways to Improve OS Data Collection, Analysis
Researchers from FDA and several other entities say overall survival (OS) remains a critical indication of safety for regulatory decisions and a key aspect of FDA’s Project Endpoint. Writing in Clinical Cancer Research, the researchers say it is unfortunate that in the pursuit of earlier endpoints, many registrational clinical
Biologics
Stakeholder Comments on Cell, Gene Guidance
The American Society of Gene & Cell Therapy says it would like FDA to clarify aspects of its draft guidance on considerations for using human- and animal-derived materials in the manufacture of cellular and gene therapy and tissue-engineered medical products. Its comment letter asks for clarifications on these
Drugs
FDA Publishes ICH Bioequivalence Guidance
FDA has published the International Council for Harmonization M13A consensus guideline, Bioequivalence for Immediate-Release Solid Oral Dosage Forms, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation, such as
Devices
FDA Clears Life Spine Sacroiliac Fixation Device
FDA has cleared a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System. The next-generation device can be utilized through a sacral alar iliac trajectory in S1 or S2 to provide maximum fixation across the sacroiliac joint, the company says. It features implants paired
Drugs
FDA May Allow Novel Carve-Ins: Attorneys
Axinn attorneys Matthew Murphy and Aaron Savit say a recent regulatory decision on a generic form of Novartis’ chronic heart failure drug Entresto (sacubitril/valsartan) may signal some agency flexibility to consider novel carve-in labeling modifications as part of a Section viii skinny labeling strategy. Writing in an online
FDA Policy/General
Medical Device User Fee Rates
Federal Register notice: FDA is announcing the medical device user fee rates for fiscal year 2025. They are: * Premarket application — $540,783 * Panel-track supplement — $432,626 * De novo classification request — $162,235 * 180-day supplement — $81,117 * Real-time supplement — $37,855 * 510(k) submission — $24,335 * Annual fee
Drugs
Prescription Drug User Fee Rates Set
Federal Register notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2025. They are: * Application requiring clinical data — $4.3 million * Application not requiring clinical data — $2.155 million * Program fee — $403,889 To view the notice, click here.
Devices
Amco Illegally Selling AED Batteries: FDA
A 3/11-3/20 FDA inspection at the Amco International Manufacturing & Design manufacturing facility in Brooklyn, NY, determined that it manufactures replacement batteries for automated external defibrillators (AED) and that the medical devices do not have an approved PMA in effect. A just-released 6/25 Warning Letter
Drugs
OSE Involved in 55 Novel Drug Approvals
The CDER Office of Surveillance and Epidemiology (OSE) 2023 annual report says OSE contributed to 55 novel drug and therapeutic biologic approvals in 2023. The report says OSE staff also were either the signal identifier or safety lead for about 80% of the 206 newly identified safety signals for marketed
Drugs
Vertex NDA for Pain Drug Accepted for Review
FDA has accepted for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pain. “Suzetrigine has the potential to be the first new class of medicine to treat acute pain in over 20 years,” the company says, adding that
FDA Policy/General
Generic Drug User Fee Rates for FY 2025
Federal Register notice: FDA is announcing fiscal year 2025 rates for generic drug user fees. They are: * ANDA — $321,920 * Drug master file — $95,084 * Active pharmaceutical ingredient (API) domestic facility — $41,580 * API foreign facility — $56,580 * Finished dosage form (FDF) domestic — $231,952 * FDF foreign — $246,952 * Contract
Drugs
FDA Clears Varian Microwave Ablation
FDA has cleared a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue. “IntelliBlate produces large, controlled spherical ablation zones,” the company says, adding that the device has the option to utilize single or dual probes, with each having linked or independent controls. The device
Drugs
Require Nasal Spray Food Studies: Aquestive
Aquestive Therapeutics has petitioned FDA to not approve any application for a nasal spray drug product that omits studies characterizing food effects if the active moiety, when separately approved for oral use, has demonstrated a food effect. The 7/29 petition specifically asks that the agency: * refuse to approve any
Drugs
Amazon, Walmart Illegally Sell Chemical Peels
FDA says the Amazon and Walmart Web sites are illegally selling chemical peel drug products that are unapproved new drugs. In 7/25 Warning Letters, FDA says Amazon markets the MOOYAM TCA 50% and Skin Beauty Solutions lactic acid skin peel 90%, while Walmart markets the Skin Beauty Solutions product.
Drugs
FDA Denies Public Citizen Tramadol Petition
FDA has denied a Public Citizen 11/6/2019 petition asking that it and the Drug Enforcement Administration (DEA) open proceedings to reschedule tramadol from Schedule 4 of the Controlled Substances Act to Schedule 2 “because the drug has a high potential for abuse, with use potentially leading to severe
Drugs
Novartis sNDA for Scemblix Expanded Use
FDA has accepted for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drug’s expanded use in treating newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Currently, Scemblix is approved for adult patients with Ph+ CML-CP who
Drugs
Syndax Leukemia Review Extended by FDA
FDA has extended by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. The agency says the extension is necessary to review supplemental information provided in response to its requests.