Drugs
FDA has issued a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firm’s Utsunomiya, Tochigi, Japan facility 3/25 to 4/2. The agency cited Chugai over its procedures for preventing microbiological contamination of drug products because they did not include adequate validation of
Drugs
FDA has released a final guidance (XXINSERT LINKXX) entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” The agency says oligonucleotide therapeutics are “an emerging therapeutic modality with increasing numbers of drugs in development.” The document provides recommendations for certain evaluations during development of oligonucleotide therapeutics, including: (1) characterizing
FDA Policy/General
Federal Register notice: FDA is announcing a proposed administrative order entitled “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.’’ The proposed order, if finalized, will require a warning on the labeling of such OTC drug products containing acetaminophen to
Devices
Teleflex and subsidiary Arrow International are recalling (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits after determining that a manufacturing error may cause the device’s balloon to become overtwisted. “This issue may prevent the balloon from fully inflating, cause
Devices
Getinge is recalling (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within the vaporizer after the device was used with low water content sevoflurane manufactured by Piramal or Baxter. Sevoflurane used in the vaporizer may degrade to hydrogen fluoride, a recall notice says, adding
Biologics
Novavax has submitted an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. “The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target
Drugs
FDA has posted a final guidance entitled “Diabetic Foot Infections (DFI): Developing Drugs for Treatment.” The document addresses the agency’s current thinking regarding the overall development program and clinical trial designs for developing drugs to support an indication for treating DFI. FDA says that important considerations for developing such
Drugs
FDA has approved an expanded use for Amgen’s Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase, regardless of measurable residual disease status. The company says the approval is based
Drugs
CDER says it has added three examples of Bayesian statistical analysis plans to its Center for Clinical Trial Innovation Supplemental Analysis Demonstration Project Web page. An online post says the demonstration project “seeks to advance the understanding of Bayesian statistical methods and establish processes for integrating these approaches into clinical
Drugs
The U.S. Supreme Court 6/13 unanimously rejected a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex) by finding that the plaintiffs, a group of anti-abortion doctors, lacked Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.
Biologics
FDA is updating its advice on this fall’s Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S. “Based on the most current available data, along with the recent rise in cases of Covid-19 in areas of the country, the agency
Biologics
Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy did not meet its primary endpoint of improvement in motor function. The primary endpoint was assessed by the change in the North Star Ambulatory
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a person that has an approved or pending drug product application. The FDA action is based on Shaver’s felony conviction for conspiring to distribute misbranded and counterfeit cough syrup
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Richard B. Smith III for five years from importing or offering for import any drug into the U.S. The agency bases the action on Smith’s felony conviction for receiving misbranded drugs in interstate commerce and delivering them for pay
Drugs
CDER’s Emerging Drug Safety Technology Meeting (EDSTM) program gives applicants with an approved application and/or other relevant parties an opportunity to meet with CDER staff to discuss their research, development, and use of artificial intelligence or other emerging technology in pharmacovigilance (PV). CDER Office of Surveillance and Epidemiology
Drugs
FDA says a final report on the Drug Supply Chain Security Act (DSCSA) pilot project program has been issued to mark the conclusion of the pilot. “All supply chain stakeholders can benefit from the information gathered and lessons learned,” an online post (includes a link to the final report) says.
Drugs
FDA has published an International Council for Harmonization guidance, M10 Bioanalytical Method Validation and Study Sample Analysis Questions and Answers, in response to questions posed to the M10 draft guidance. The document says it was created to provide clarity around some of the bioanalytical issues covered in the guidance. “This
Drugs
FDA has granted accelerated approval for Bristol Myers Squibb’s Augtyro (repotrectinib) for adult and pediatric patients aged 12 and older with NTRK (neurotrophic tyrosine receptor kinase) gene fusion-positive solid tumors that are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
Devices
Megadyne is recalling (Class 1 — market withdrawal) its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned in procedures using the devices. “The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries,” a
Biologics
FDA has recommended that Toronto, Canada’s Revive Therapeutics submit an IND for agency evaluation of the company’s bucillamine, described as an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for Long Covid. In a Type C meeting with company executives, FDA officials
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on an 11/20/2023 request for information that is intended to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.” The collection supports the agency’s compounding program that is intended to protect patients from unsafe, ineffective,