Biologics
FDA says Exocel Bio in San Diego, CA, is selling unapproved exosome products through a Facebook page and YouTube channel. A 5/7 CBER letter cites examples of promotional statements that demonstrate the firm intends the products for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The
Drugs
CDER director Patrizia Cavazzoni says the reorganization of FDA’s Office of Regulatory Affairs regarding inspection activities will create a “unified compliance discipline and program that will reside within the Center and work hand in hand with the Office of Regulatory Affairs and the inspectorate.” Providing an online update to
Drugs
FDA has granted Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran (AOC 1001) and its use in treating myotonic dystrophy Type 1 (DM1). The investigational treatment is “designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies,” the company
Devices
FDA is alerting healthcare providers and facilities about its ongoing safety and quality concerns with some Getinge/Maquet cardiovascular medical devices. The affected devices are the Getinge/Maquet/Datascope hybrid and rescue intra-aortic balloon pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets. A 5/8
Biologics
As directed by a presidential Executive Order, FDA, EPA and the Department of Agriculture have developed a joint regulatory plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. An FDA statement (includes a link to the plan) says the plan “incorporates processes and timelines
Drugs
FDA has responded to a Kaiser Permanente petition submitted more than 14 years ago (12/2009) asking the agency to revise its standards, procedures, and guidelines for developing, implementing, and evaluating risk evaluation and mitigation strategies (REMS). The FDA response says Kaiser specifically asked the agency to: * increase the transparency
Drugs
FDA has granted China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal cancer. The therapy was previously given a fast-track designation for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma. NECTIN-4 is an adhesion molecule expressed
Drugs
Tandem Diabetes Care is recalling (Class 1) its t:connect mobile app (version 2.7 released 2/12) on the Apple iOS platform that is used with the company’s t:slim X2 insulin pump with Control-IQ technology. An agency recall notice says the recall is a device correction
FDA Policy/General
Federal Register notice: FDA is announcing a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics NDA for midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder. The panel will be asked to discuss the overall benefit-risk profile of MDMA, including the
Biologics
CBER director Peter Marks told the American Society of Gene & Cell Therapy conference on 5/8 that if FDA is going to err in granting accelerated approval for a gene therapy product to treat a rare disease, he would rather err on the side of bringing a potentially useful
Drugs
Three Winston & Strawn attorneys say the Supreme Court declined to hear an appeal of a 1st Circuit Court of Appeals decision upholding implied preemption of a putative class action suit against McNeil Nutritionals over its Lactaid dietary supplement. The attorneys write in an online post that the suit claimed
Devices
An 11/6-11/11/2023 FDA inspection at China’s Bioptimal International manufacturing facility in Singapore identified Unapproved Device, Quality System Regulation, and Medical Device Reporting violations in the firm’s manufacturing of the Thermodilution Catheter and Pulmonary Artery Monitoring Catheter. A just-released 4/3 Warning Letter says
Devices
Federal Register notice: FDA is announcing that the CDRH Office of Product Evaluation and Quality has modified its organizational structure. The new structure was approved by the HHS 12/21/2023 and it became effective 1/22. To view the notice, click here.
Drugs
Responding to an 8/30/2022 petition submitted by HBT Labs, FDA says it has determined that cancer drug paclitaxel particle bound particles for injectable suspension (albumin-bound) 100 mg/vial and Abraxane (paclitaxel protein bound particles for injectable suspension) are pharmaceutically equivalent and bioequivalent, and can be expected to
Drugs
A 12/5-12/16/2022 FDA Bioresearch Monitoring Program inspection at DBC Research in Tamarac, FL, operated by Dr. Kevin Bender, looked at the protocols for three clinical trials. A 5/2 Warning Letter says Bender failed to take adequate precautions to prevent theft or diversion of an investigational
Drugs
Endo Health Solutions has been ordered to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeitures related to distributing misbranded Opana ER, an opioid medication. In a statement, the Department of Justice says the company pleaded guilty on 4/18 to one count of
Devices
Six Hogan Lovells attorneys say litigation challenging the FDA final rule asserting the agency’s authority to regulate laboratory-developed tests remains likely, based on longstanding industry claims that the rulemaking exceeds FDA’s authority. Writing in a comprehensive analysis of the final rule that will become effective 7/5,
FDA Policy/General
The House Energy and Commerce Committee has announced a 5/22 hearing titled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices,” which will hear testimony from CDER director Patrizia Cavazzoni, CBER director Peter Marks, and CDRH director Jeff Shuren. “Given the increased funding provided in the most recent
Devices
FDA has approved a Geneoscopy PMA for its colorectal cancer stool-based screening test ColoSense, indicated for adults aged 45 years and older who are at typical average risk for developing colorectal cancer (CRC). Designated as a breakthrough device earlier by FDA, the company says )the test is the “first
Biologics
FDA is announcing a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for donanemab solution for intravenous infusion, indicated for treating early symptomatic Alzheimer’s disease. In March, FDA decided to delay its review decision on the BLA by requiring
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “REMS Logic Model: A Framework to Link Program Design With Assessment.” The document describes the logic model as a recommended framework that provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The
Drugs
The House Committee on Oversight and Accountability is stepping up pressure on FDA and its oversight imported Chinese active pharmaceutical ingredients and finished drugs. In a 5/6 letter to FDA commissioner Robert Califf, Committee chair James Comer (R-KY) calls on FDA to “do everything in its power to