Devices
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices. The existing pilot program, which is limited to PMA devices, is intended to streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities. It was established to encourage
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance for industry entitled Inspection of Injectable Products for Visible Particulates. The document addresses the development and implementation of a risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective
FDA Policy/General
Federal Register notice: FDA is classifying the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls). The action is based on a de novo classification request by Ethicon Endo-Surgery for its Percutaneous Surgical Set with 5mm or 10mm Attachments. The agency identified it
Drugs
CDER has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registration and the results reporting requirements. Speaking during a virtual Food and Drug Law Institute conference 12/9, CDER Office of Compliance director Donald Ashley said ClinicalTrials.gov compliance continues to be an area of “focused attention for CDER”
Drugs
FDA researchers are working with industry and clinicians to determine the best way to apply modeling information to improve pediatric dose selection for renally eliminated drugs in the pediatric patient population. A new CDER Web posting notes recent research findings that renal function models and equations are “valuable tools for
Devices
FDA is alerting clinical laboratory staff and health care providers that false reactivity or false positive Rapid Plasma Reagin (RPR) test results are possible when using Bio-Rad Laboratories’ BioPlex 2200 Syphilis Total & RPR kit. A false positive can occur in some people who received a Covid-19 vaccine,
Biologics
Former FDA Office of Vaccines Research and Review deputy director Philip Krause and former FDA acting chief scientist Luciana Borio say the Biden administration has made recent vaccine decisions without consulting outside scientific experts, reversing what had been standard practice. Writing in a Washington Post op-ed, the two cite
Devices
Sens. Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Medical Device Integrity Act to give FDA the authority to request records and require that medical device manufacturers comply with the requests. In a statement, the senators say the measure will better prepare the U.S. for
Drugs
FDA has updated the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic” to include approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update and for which the agency has not approved an ANDA referencing the NDA product.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The document is intended to provide clarity regarding references to the terms “device” and “counterfeit device.” To
FDA Policy/General
Federal Register notice: FDA is classifying the traumatic brain injury eye movement assessment aid into medical device Class 2 (special controls). The action is based on a de novo classification request by Oculogica for its EyeBox. The agency identified it as a prescription device that uses a patient’s tracked
Drugs
Biogen says it will submit to FDA in 3/2022 a final clinical trial protocol for a required post-marketing trial of its controversial Alzheimer’s drug Aduhelm (aducanumab). Aduhelm was granted accelerated approval earlier this year amid a firestorm of criticism over the agency’s use of the pathway
Drugs
FDA has denied a 7/19 petition submitted by Buchanan Ingersoll Rooney asking that the agency: * review the basis for submission of an ANDA by Eugia Pharma Specialties; * determine that the ANDA should have been filed as a 505(b)(2) NDA; * conclude that FDA should have issued a refuse-
Drugs
The development of checkpoint inhibitors needs more coordination and collaboration and less competition. That’s the view of FDA Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver, writing in the New England Journal of Medicine. Checkpoint inhibitors are a type of immunotherapy that works
Drugs
In denying a Par Sterile Products 11/8 petition involving an Eagle Pharmaceuticals ANDA for vasopressin citing Vasostrict as the reference-listed drug, FDA says it will refer the matter to the Federal Trade Commission to investigate a potential anti-competitive business practice. FDA says that while it denied the
Drugs
FDA has released a draft guidance entitled Inspection of Injectable Products for Visible Particulates. The document addresses the development and implementation of a “holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct,
Devices
CDRH is planning to release “very soon” a long-awaited proposed rule to modernize the medical device Quality System Regulation (QSR) by harmonizing and “supplanting” existing requirements with the specifications in the International Organization for Standardization’s (ISO) 13485:2016. Speaking at a virtual Food and Drug Law Institute (FDLI)
Drugs
FDA has modified a Risk Evaluation and Mitigation Strategies (REMS) program for mifepristone, a drug used in early abortion and miscarriage care. While the agency did determine that the REMS continues to be necessary to ensure that the benefits of the drug outweigh its risks, it also concluded that it
Devices
FDA says the 10/27 Getinge/Datascope/Maquet recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is Class 1. An agency notice says the company recalled 4,338 devices in the U.S. manufactured between 12/2011 and the present and distributed 3/6/2012 to 10/
Drugs
An FDA 12/7/20-1/20/21 inspection at Dental Technologies, Lincolnwood, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and Quality System (QS) regulations for medical devices. An 11/30 Warning Letter identifies the specific violations as: * failing to thoroughly investigate any
Biologics
FDA says there are revisions to two fact sheets for the Janssen (Johnson & Johnson) Covid-19 vaccine. An agency announcement says the Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers now include a Contraindication to the administration of the Janssen Covid-19
Devices
FDA has published a draft guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Comment, Communications, and Other Public Documents, to promote clarity regarding references to the terms “device” and “counterfeit device.” The document says that as a result of the enactment