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
Devices
FDA has cleared an Aidoc 510(k) for its artificial intelligence (AI) component for flagging large-vessel occlusion in head computed tomography angiography scans. The latest AI module joins a previous cleared module for flagging and prioritizing intracranial hemorrhage to provide a comprehensive AI package for identifying and triaging both
Devices
Galemed has recalled (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure when initially set up on a patient. This malfunction is traced to a dislodged valve not being properly seated, resulting in loss of pressure in the system, a recall
Drugs
FDA has accepted for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly. According to Chiasma, acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, which leads to significant health problems and early death if
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab (Genentech’s Avastin) for the maintenance treatment of women with advanced ovarian cancer whose disease has shown a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The
FDA Policy/General
Meeting on Asbestos in Talc and Cosmetic Products Federal Register notice: FDA announces a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” 01/10/2020 FDA Withdrawing 249 ANDAs Over Annual Reports Federal Register notice: FDA proposes to withdraw approval of 249
Drugs
Evotec has entered into a definitive agreement with Aptuit under which Evotec will acquire all operational business of Aptuit for $ 300 million that will expand Evotec’s role as a leading player in integrated outsourced drug discovery and development solutions. LabCorp has agreed to purchase private contract research organization (CRO)
Devices
FDA has released a draft guidance on “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.” The document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-
Drugs
FDA has issued SCA Pharmaceuticals (Little Rock, AR) a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility. For example, the agency said that each batch of drug product required to be free of objectionable microorganisms is not subjected to appropriate laboratory testing.