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FDA has published a draft guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Comment, Communications, and Other Public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Commenting on an International Council for Harmonization (ICH) draft guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, the United States Pharmacopeia asks how the ICH guidance, when finalized, will affect an FDA draft guidance on quality considerations for continuous manufacturing.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
Drugs
Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the risk of hospitalization or death for any cause by 89% compared to placebo in non-hospitalized, high-risk adult patients with Covid and treated within three days
Biologics
A 7/8-7/19 FDA inspection at Cooper Institute for Advanced Reproductive Medicine, Houston, TX, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 12/15 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Drugs
FDA has published an immediately effective guidance, Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the Covid-19 Public Health Emergency, communicating its temporary policy for certain REMS (risk evaluation and mitigation strategies) requirements for tocilizumab (Genentech’s Actemra) due to the shortage related to the Covid-
Devices
FDA has approved Svelte Medical Systems’ Slender IDS fixed-wire and Direct RX rapid-exchange drug-eluting stent systems to treat coronary artery disease. The company says the two systems, incorporating the same stent, bioresorbable drug coating, and balloon technologies, achieved 1.5% clinically-driven target lesion revascularization at one
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products. The document provides FDA’s current thinking on the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. To view the notice,