Devices
FDA has cleared an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in children ages 16 to 30 months old. The updated device displays curated scenes of social interactions on a portable tablet. “Eye-tracking technology measures more than 120 focal preferences
Biologics
Senators Mike Lee (R-UT), Ben Ray Luján (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) have introduced the Biosimilar Red Tape Elimination Act to increase competition within the biosimilar drug market and increase access to low-cost drugs. The legislation would deem approved biosimilars as
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CGT) Products.” The document provides recommendations on product comparability and the management of manufacturing changes for investigational and licensed CGT products. It also offers the agency’s current thinking
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.” The document describes the factors FDA considers when determining whether an applicant has demonstrated
Drugs
FDA has approved a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those on dialysis. The approval now extends the drug’s use across all stages of renal disease, the company says. Approval was based on data from a
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in the selection of nonvoting industry representatives to serve on CDER advisory committees. The agency is also requesting nominations for nonvoting industry representatives to serve on the committees. To view the notice, click here.
Biologics
FDA has published a draft guidance, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products, to give sponsors of INDs and applicants of BLAs for cellular and gene therapy (CGT) products recommendations about product comparability and the management of manufacturing changes for investigational and licensed CGT products. The
Drugs
FDA has approved a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over-the-counter status. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing
Biologics
FDA has accepted for review a Dr. Reddy’s Laboratories BLA for its proposed biosimilar rituximab (Genentech’s Rituxan) candidate, indicated for treating adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. Dr. Reddy’s says its submission
Drugs
FDA has published a draft guidance, Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act, with information for holders of approved applications for human prescription drugs who are required to conduct postmarketing studies or
FDA Policy/General
Federal Register notice: The FDA is issuing an order to withdraw its 1/25 debarment of former Aegerion Pharmaceuticals sales representative Mark Moffett because the U.S. Court of Appeals for the First Circuit vacated his convictions and sentence. The government alleged that Moffett played a role in persuading physicians
FDA Policy/General
Federal Register notice: FDA is announcing a 9/20 Pediatric Advisory Committee meeting to discuss appropriate development plans for establishing safety and effectiveness of artificial womb technology devices, including regulatory and ethical considerations for first-in-human studies. To view the notice, click here.
Drugs
While FDA continues to pursue a new regulatory paradigm for laboratory-developed tests (LDTs), the agency is starting a new pilot program to add more regulatory teeth to LDTs that are used without an approved companion diagnostic for certain oncology drugs. Speaking at a Friends of Cancer Research (FOCR) public
Devices
A 12/5-12/13/2022 FDA inspection at Zyto Technologies in Lindon, UT, determined that the company manufactures the Zyto Hand Cradle Galvanic Skin Response device and associated proprietary software used to scan patients to identify “stressors” and “balancers.” A just-released 6/21 Warning Letter says some of
Devices
FDA has posted an online information page on the surgical mesh used for hernia repair. The page defines hernias and their types and causes, treatment options, surgical mesh, and additional resources. On the page, FDA discusses non-surgical and surgical options for treating hernias and explains how surgical mesh is
Devices
Draeger Medical is recalling (Class 1) its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of a depleted battery. The device stoppages also occurred after being re-connected to AC power, a recall notice says. “The ventilator may not automatically switch back
Drugs
An 11/28-12/2/2022 FDA inspection at the NeilMed Pharmaceuticals drug manufacturing facility in Santa Rosa, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other issues in the production of finished drugs. A just-released 5/26 Warning Letter says the specific CGMP violations
Drugs
A 7/10 VeganMed petition asks FDA to revise existing regulations and policies to require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal-derived or contain animal byproducts. “Under the current FDA regulatory framework,” the petition says, “consumers who want to avoid
Devices
FDA has approved Boston Scientific’s Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation (DBS) System to provide clinicians with with what the company calls “simple and actionable data for efficient programming” in treating people with Parkinson’s disease or essential
Biologics
FDA has issued Warning Letters to two medical firms for violations involving human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 6/27 Warning Letter went to New Hope Center for Reproductive Medicine in Virginia Beach, VA, following a 12/8/22-1/23/23 agency inspection
Biologics
Three Goodwin attorneys analyzed Warning Letters issued following Bioresearch Monitoring (BIMO) program inspections in 2022. Their online post says that BIMO conducted 504 inspections of clinical investigators in FY 2022. Of the 504, nine resulted in a classification of “official action indicated” and 87 resulted in a classification of “voluntary
FDA Policy/General
Federal Register notice: FDA is inviting consumer organizations to (XXX INSERT XXX)notify the agency if they are interested in participating in selecting voting and nonvoting consumer representatives to serve on its advisory committees or panels. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve