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FDA has published a draft guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Comment, Communications, and Other Public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
FDA Policy/General
Federal Register notice: FDA is classifying the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls). The action is based on a de novo classification request for its IB-Stim. The agency has identified it as a device that stimulates nerves remotely from the source of
FDA Policy/General
Federal Register notice: FDA is classifying the endoscopic transhepatic venous access needle into Class 2 (special controls). The action is based on a de novo classification request by Cook Ireland for its EchoTip Insight Portosystemic Pressure Gradient Measuring System. The agency has identified it as a device that is inserted
FDA Policy/General
Federal Register notice: FDA is proposing to require PMAs for spinal spheres, a preamendment device, for use in intervertebral fusion procedures. The proposed PMA requirement is based on the device’s risks to health, such as the need for reoperation resulting from a failed spinal sphere device or component or
Drugs
Citizens Against Government Waste health and science policy director Elizabeth Wright says the Biden administration’s Build Back Better Act includes provisions from the Elijah E. Cummings Lower Drug Costs Now Act that will hurt the generic drug industry. In an Inside Sources article reprinted by the American Institute for
Drugs
Commenting on an International Council for Harmonization (ICH) draft guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, the United States Pharmacopeia asks how the ICH guidance, when finalized, will affect an FDA draft guidance on quality considerations for continuous manufacturing. In its comment letter, Lilly says it has
Drugs
FDA has approved AbbVie’s JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from two pivotal Phase 3 trials, SELECT-PsA
Drugs
FDA has approved a new indication for Bristol-Myers Squibb’s Orencia (abatacept) to be used in combination with certain immunosuppressants to prevent acute graft versus host disease. An agency announcement says the disease occurs when donor bone marrow or stem cells attack the graft recipient. Orencia may be used
Drugs
FDA has approved a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from a Phase 3 study that showed
Drugs
A 5/25-6/3 FDA inspection at Sanitor Corp., Stanton, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in the firm’s work manufacturing drug products to bleach or lighten the skin that FDA says are unapproved new drugs. An 11/29 Warning
Devices
A 7/28-8/25 FDA inspection at the DeVilbiss Healthcare medical device operation in Somerset, PA, found Quality System regulation violations in the firm’s manufacturing of oxygen concentrators, nebulizers, suction units, non-continuous ventilators, and related accessories. An 11/23 Warning Letter says specific violations were: * failing to
Drugs
A California federal judge has suspended the state’s law banning drug industry “pay for delay” deals, saying the first-in-the-nation law intended to increase the flow of generic drugs likely violates out-of-state commerce protections. The judge sided with a group of generic drug manufacturers in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use” (OMB Control Number 0910-0814). The agency is revising the collection to account for reporting burdens attendant to other expanded access submissions, including commercial INDs that involve large groups
FDA Policy/General
FDA commissioner nominee Robert Califf says, if confirmed, “I’m going to be very aggressive in this area of medical misinformation (on social media) because one could argue that it is killing more people than any particular disease right now.” Califf’s hard line on social media promotions came in
FDA Policy/General
Federal Register notice: FDA has announced a 2/10/2022 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Innovent Biologics BLA for sintilimab for injection, indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with Stage
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of six ANDAs from multiple applicants after they notified the agency that the products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use” (OMB Control Number 0910-0814). The agency is revising the collection to account for reporting burdens attendant to other expanded access submissions, including commercial INDs that involve large groups