Drugs
FDA has published a draft guidance, Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology, with recommendations to sponsors for the clinical development of drug and biological products intended to prevent and treat chemotherapy-induced peripheral neuropathy (CIPN) in oncology patients. The document pertains
FDA Policy/General
King & Spalding has added former FDA associate commissioner for policy Lauren Roth as a partner on the FDA and Life Sciences team in the firm’s Washington, D.C. office. Roth left FDA 9/2024 after serving eight years in senior leadership roles, such as senior advisor to FDA’
Devices
A 6/25-7/11/2024 FDA inspection at Xoran Technologies in Ann Arbor, MI, identified Quality System Regulation violations in the firm’s manufacturing of computed tomography systems and supporting software. A just-released 12/9/2024 Warning Letter says the specific violations were: * failure to establish and maintain
Devices
A 4/22-7/17/2024 FDA inspection at Phillips Precision in Elmwood Park, NJ, found Quality System Regulation violations in the firm’s contract manufacturing of orthopedic implants and instruments. A just-released 12/9/2024 Warning Letter says specific violations were: * failure to ensure that when the results
Devices
AdvaMed recommends that FDA revise the title of CDRH’s Device Trial Participation Snapshots to reflect that the program intends to provide key information about clinical trials that support the agency’s approval of new medical devices. The association’s comment letter also makes these recommendations: * allow sponsors to review
Drugs
The Department of Justice (DoJ) says a former McKinsey & Company senior partner pleaded guilty 1/10 to obstructing justice related to his work on opioids with Purdue Pharma. A department statement says Martin Elling, an American citizen who lives in Bangkok, Thailand, pleaded guilty to a one-count information
Drugs
FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn’s disease in adults. Omvoh was originally approved 10/2023 as a first-in-class treatment for moderately to severely active ulcerative colitis in adults. The new approval is based on data from the
Drugs
Getinge and its subsidiary Maquet Cardiovascular are recalling (Class 1 instructions for use update) the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the possibility of two failure modes being experienced during use. A recall notice describes the failures as a bent or detached
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 ANDAs from multiple applicants after they told the agency that the drug products were no longer marketed and requested such action. To view the notice, click here.
Drugs
FDA has published a Federal Register notice indicating its intention to deny the Vanda Pharmaceuticals NDA for tradipitant capsules, 85 mg, in its present form and offering the company the opportunity to request a hearing with the commissioner. The notice says the NDA seeks an indication for “the treatment of
Drugs
FDA has accepted for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug-releasing system for treating patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, with or without papillary tumors. The company says the submission
Devices
FDA inspections at three Integra Lifesciences medical device facilities (Mansfield, MA, 3/12/2024-6/5/2024; Plainsboro, NJ, 4/9/2024-8/22/2024; and Princeton, NJ, 3/12/2024-8/22/2024) found Quality System Regulation violations in the firm’s manufacturing of neurological and neurosurgical medical devices.
Devices
A 7/30-9/24/2024 FDA inspection at Hologic in Marlborough, MA, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of Class 2 implantable radiographic markers such as its BioZorb product line. A just-released 12/18/2024 Warning Letter says specific violations
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued Novo Nordisk a priority review voucher because its rare pediatric disease product, Alhemo (concizumab-mtci), met the agency’s issuance criteria. The product was approved 12/20/2024 as a once-a-day treatment to prevent or curb the frequency
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of 12 NDAs from multiple applicants after they requested their withdrawal because the affected products are no longer marketed. To view the notice, click here.
Drugs
The HHS Office of Inspector General (OIG) says its review of a sample of 24 drugs approved via the FDA Accelerated Approval pathway identified concerns with three of the approvals. The OIG report says that because accelerated approval does not require that a drug demonstrate a clinical benefit before it
Drugs
FDA says the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine an acceptable intake (AI) limit for N-nitrosamine impurities in drugs has expedited the regulatory review of drug safety assessments submitted by drug companies as an AI limit can be identified more efficiently and with greater transparency
Drugs
The Association for Accessible Medicines (AAM) says FDA should publish guidance for oligonucleotide product development for ANDAs, particularly for topics not included in product-specific guidances such as recommendations for immunogenicity and inflammation risk assessments and for demonstration of comparability of impurities. The request is included in AAM’s comments
Drugs
FDA has accepted for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. The submission is based on data from the Clarity AD (Study 301) open-label extension and
Devices
FDA has cleared an Icotec 510(K) for the use of its BlackArmor carbon fiber implants for treating de novo spinal infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. Icotec’s implant offers “reduced artifacts from radiolucent Carbon/PEEK material,” which the company says enables
Devices
FDA has granted Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimer's disease. The company says current diagnostic methods (e.g., PET scans and lumbar puncture cerebrospinal fluid analysis) are “invasive, costly, and logistically challenging… Spear Bio's pTau
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Generic Drug User Fee Program.” The revision is related to the agency’s communication program that encourages the submission of sponsor questions at any point in their development and application preparation processes. The collection is being revised