Devices
CDRH has qualified the Apple Watch’s Atrial Fibrillation (AFib) History Feature as a medical device development tool (MDDT) for use as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “New Animal Drugs for Investigational Use — 21 CFR 511.” The collection supports implementation of agency statutory and regulatory requirements regarding the approval of new animal drugs. For example, a new animal drug application cannot be approved until,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the flexible and innovative approach outlined in an FDA draft guidance on key information and facilitating understanding in informed consent. A PhRMA comment letter urges FDA and the HHS Office for Human Research Protections (OHRP) “to continue to embrace
Drugs
Writing in the open-source Journal of General Internal Medicine, CBER director Peter Marks and Brown University medical school professor Eli Adashi say that it appears that decentralized clinical trials (DCTs) are “a paradigm whose time has come, especially since by providing more broadly applicable results they may provide important
Drugs
FDA should use accelerated approval and other regulatory techniques to speed the development and approval of treatments. That’s the thesis in a Salon commentary written by the executive director of the National Mucopolysaccharidoses Society. The commentary says that to date, agency regulators have not used accelerated approval, even for
Drugs
Doctors for America (DFA) says FDA should finalize its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for regulated products with strong recommendations for industry compliance and providing ongoing support and resources to facilitate the adoption of inclusive practices in clinical research.
Devices
A 5/8-5/11/2023 FDA inspection at the P.T. Sankei Medical Industries manufacturing facility in Banten, Indonesia, found Quality System and Medical Device Reporting violations in its manufacturing of adulterated and misbranded medical devices. A just-released 9/19/2023 Warning Letter says the company manufactures a
Drugs
FDA has approved an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients with epilepsy between two to five years of age. Aquestive says it developed Libervant as an alternative
Devices
FDA has cleared a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac (SI) joint fusion construct to be used with the Liberty-SI lateral transfixing system. The device is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.” In certain public health emergencies, there may be need for certain in vitro diagnostic devices (IVDs) to
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” The document describes the factors the agency intends to assess when deciding to issue an enforcement policy regarding device manufacturers’ offering of certain unapproved tests and unapproved
Drugs
AdvaMed says FDA should update its draft guidance on key information and facilitating understanding in informed consent “to be clear about what levels of reimbursement, compensation, and recruitment incentives are problematic for medical device studies.” The association’s comment letter also suggests that HHS modernize its human subject protection guidance,
Drugs
FDA has approved Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvie’s Humira (adalimumab) for treating multiple chronic inflammatory diseases. Boehringer’s low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since 7/2023. “The availability
Drugs
The National Community Pharmacists Association (NCPA) says there are many comments it has submitted to FDA over the years that still have not been addressed by the agency. The comment is included in the NCPA statement submitted in advance of the agency’s 5/14 Drug Compounding Annual Listening Session.
Biologics
CBER says it is recognizing as acceptable for use by manufacturers of blood and blood components the 1/2024 document entitled “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, version 4.0.0.” An FDA guidance, Recognition and Use of a
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Additionally, the agency is phasing out its general
Devices
An FDA 10/27-11/3/2023 inspection at Pinnacle Labs of Tennessee, doing business as Pinnacle BioLabs in Nashville, TN, identified multiple violations in the firm’s marketing and distribution of the Second Generation FIT Fecal Immunochemical Test. A just-released 4/17 Warning Letter says the company is
Devices
A 1/16-1/19/2023 FDA inspection at the Future Diagnostics Solutions facility in Gelderland, Netherlands, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of the STAT-IntraOperative Intact PTH (parathyroid hormone) Immunoassay Kits. A just-released 5/11/2023 Warning Letter says the
Drugs
The Federal Trade Commission (FTC) has sent warning letters to 10 companies and notified FDA it is challenging more than 300 patents across 20 different brand name products listed by the companies in the FDA Orange Book. In a statement, FTC says it is disputing the patent listings as improper
Drugs
FDA has issued a safety alert on the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine, 6-mercaptopurine, and 6-thioguanine), immunosuppressants with a known risk of hepatotoxicity and currently labeled about the risk of fetal harm when used during pregnancy. “Pregnant patients
Drugs
The CDER Office of New Drugs (OND) says it was involved in 55 novel drug approvals in 2023. The approvals are one of the OND successes listed in its 2023 Annual Report. Other report highlights are: * 25 public advisory committee meetings; * over 3,400 formal meetings with drug development program
Biologics
FDA has granted Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on efficacy data from the innovaTV 301 (NCT04697628), an open-label, active-controlled trial that enrolled 502 patients with