Drugs
The FDA Anesthetic and Analgesic Drug Products Advisory Committee will discuss 1/16 Durect Corp.’s 10/2019 response to a 2/12/14 FDA complete response letter for its Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia.
FDA Policy/General
Eight FDA staffers say they envision that machine learning will play an increasingly important role in future drug development and regulation. Writing in Clinical Pharmacology and Therapeutics, they say (membership or purchase required) that machine learning “will likely be an essential tool for data aggregation, information synthesis, pattern recognition, and
Devices
CDRH associate director for compliance and quality Erin Keith says the number of Warning Letters issued by the Center may start to climb this year as reorganization bugs that prevented sending letters on time are worked out. However, not all observers agree that reorganization is the only cause for a
Drugs
Republican leaders of the House Energy and Commerce Committee say they are reopening their 8/2018 inquiry into three opioid manufacturers — Insys, Mallinckrodt, and Purdue — to obtain additional information from the companies. In 2018, the companies were asked to provide information about their actions related to the spread of the
Drugs
A new FDA safety alert says that results from a clinical trial assessing safety of Eisai’s weight-loss drugs Belviq and Belviq XR (lorcaserin) show a possible increased cancer risk. The alert says that the cancer cause is “uncertain” and that the agency cannot conclude that lorcaserin contributes to
Drugs
FDA has placed a partial clinical hold on Innate Pharma’s TELLOMAK Phase 2 trial that is evaluating lacutamab’s efficacy and safety in patients with advanced T-cell lymphomas. The company says it has been in ongoing discussions with regulatory authorities about GMP deficiencies at its manufacturing subcontractor site
Drugs
Harvard Medical School researchers say that while the FDA approval and regulation processes for drugs have evolved and increased in complexity over the last four decades as special programs have been added and the use of surrogate measures has been encouraged, the changes have not led to a reduction in
Devices
FDA has cleared a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The guide catheter is designed to improve procedural control of therapeutic catheters, such as the Helix system, during delivery of
Devices
A new CDRH Learn Webcast module, “Production and Process Controls, Part 2: Acceptance Activities, Handling, Storage, Distribution, and Installation,” reviews the purpose of the production and process controls subsystem and describes aspects of acceptance activities, handling, storage, distribution, and installation. Presented by CDRH Division of Industry and Consumer Education consumer
Drugs
A Science investigative report says that FDA and the National Institutes of Health (NIH) are doing little or nothing to enforce a 2007 law and its 2017 final rule requiring recording of most clinical trial results in a federal database so doctors and patients can see whether new treatments are
Drugs
A 5/13-6/3/19 FDA inspection at the Health Pharma drug manufacturing facility in Rahway, NJ, found significant violations of current good manufacturing practice (CGMP) regulations. A 12/18/19 Warning Letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility
Biologics
Ultragenyx Pharmaceutical and Kyowa Kirin have submitted a supplemental BLA for Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized. The companies say that about half of patients with TIO have tumors that cannot be surgically
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Health Pharma USA Rahway, NJ (12/18): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company’s quality control unit
Drugs
A 7/1-7/5 FDA inspection at Huaian Zongheng Bio-Tech Co., Huaian, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/9 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory determination of
Drugs
Vifor Pharma, which manufactures a number of complex drugs to treat iron deficiency, is asking FDA “to take critical steps regarding the approval and therapeutic equivalence of safe and effective follow-on harder-to-copy complex drugs.” Specifically, the firm’s petition says, FDA should make clear to its stakeholders
Drugs
FDA has denied an 11/1/19 petition filed by Arent Fox asking that the agency deny approval of an NDA for Neurelis’ Valtoco (diazepam nasal spray) until additional clinical studies are conducted. The agency approved the NDA 1/10 contemporaneously with the petition denial. The petition had asked that
Drugs
Former FDA principal deputy commissioner Joshua Sharfstein says there are four things FDA and Congress should do to enhance the benefits and value and reduce the inefficiency and risks of the U.S. system of drug approval. Sharfstein’s ideas appear in a JAMA editorial accompanying a research article discussing
Devices
FDA has granted ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring and recurrence surveillance. The device is intended to enable healthcare providers across community and academic care settings access to genomic information in their laboratory. The company says that fewer than
Drugs
CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Center’s new drugs regulatory program are two of the top priorities for 2020. “Maintaining our robust postmarket surveillance and risk evaluation programs is critical for identifying new adverse events that did not appear during the product development
FDA Policy/General
Federal Register notice: FDA has exempted powered wheeled stretchers (product code INK) from premarket notification (510(k)) requirements. The devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” The document applies to infusion catheters, PTA balloon catheters for in-stent restenosis, and scoring/cutting
Drugs
Taro Pharmaceuticals has recalled one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a small amount of another drug substance (enalapril maleate) that was used to manufacture another product at the same facility. Enalapril Maleate is indicated for hypertension