Drugs
A 7/18-7/21/17 FDA inspection at Daito Kasei Kogyo, Okayama, Japan, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 1/18 Warning Letter. Specific deviations were: * failing to ensure that appropriate laboratory tests are conducted for each batch
Drugs
A 7/24-7/28/18 FDA inspection at Hunan Norchem Pharmaceutical Co., Hunan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API) , according to a 1/9 Warning Letter. Specific deviations were: * · failing to prepare and use production and control records for each
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Qualified Infectious Disease Product Designation Questions and Answers.” The document discusses available incentives for developing antibacterial and antifungal drug products that treat serious or life-threatening infections. It is also intended to serve as an information resource on FDA’
FDA Policy/General
Federal Register notice: FDA has classified the surgical smoke precipitator into Class 2 (special controls). The action is in response to a de novo classification request by Alesi Surgical for the Ultravision Visual Field Clearing System. It is a prescription device intended for clearing the visual field by precipitation of
Drugs
FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium). In a revised drug safety alert, the agency says most events are among people who are intentionally misusing or abusing
Devices
FDA has issued two final guidances explaining the procedures and criteria the agency intends to use in accepting or refusing a 510(k) or PMA submission. The guidances include checklists to identify the necessary elements and contents of a complete application. FDA says the updates in the documents address provisions
Drugs
FDA has revised its document entitled “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which contains core educational messages for those involved. It also includes more information on pain management, including principles of acute and chronic pain management; non-
Drugs
FDA has released the FDA-483 issued following a 1/16-1/19 inspection at Shilpa Medicare Limited, Raichur, Karnataka, India. Observations in the form were: * equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates
FDA Policy/General
Federal Register notice: FDA has classified the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (special controls). The action is in response to a 9/2016 de novo classification request by Claret Medical for its Sentinel Cerebral Protection System. The agency has identified the generic type
Drugs
The Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association), says a Pennsylvania federal court should not grant a motion by Johnson & Johnson and its Janssen Biotech subsidiary to dismiss a suit brought by Pfizer over its biosimilar Inflectra (infliximab), which is trying
Devices
The Pew Charitable Trusts says HHS should support incorporation of medical device identifiers, particularly implants such as cardiac stents and artificial joints, to claims data as part of efforts to promote healthcare system competition and efficiency. The group’s 1/25 letter says that adding unique device identifiers (UDIs) to
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Daito Kasei Kogyo Co. Okayama, Japan (1/18): FDA inspected the firm 7/2017 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed
Devices
FDA has cleared a Multi Radiance Medical 510(k) for the MR4 Laser technology for neck and shoulder pain relief. The clearance was based on data from a randomized, double blind, controlled study demonstrating that the device is more effective than placebo for reducing neck and shoulder pain, according to
Drugs
FDA has approved a CutisPharma NDA for Firvanq (vancomycin hydrochloride) oral solution for treating Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The company says that Firvanq will replace its FIRST-Vancomycin Unit-of-Use Compounding Kit, which has been available to pharmacists that
Drugs
FDA has released a draft guidance on “Qualified Infectious Disease Product Designation Questions and Answers.” The document provides information on implementing the FDA Safety and Innovation Act’s section on “Generating Antibiotic Incentives Now (GAIN),” which creates incentives for developing antibacterial and antifungal drug products that treat serious or life-
Drugs
FDA and Duke University’s Center for Health Policy have announced a 4/16 public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will help the agency develop a guidance on the subject. It will include discussion about various ways in which participation in clinical trials
Drugs
FDA has accepted for review a Theravance Biopharma and Mylan NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist for treating chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action target date of 11/13, and it has told the companies that an
FDA Policy/General
Federal Register notice: FDA is providing interested parties with the opportunity to submit written comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the
Drugs
FDA has updated a guidance for Institutional Review Boards and Clinical Investigators to revise its “Payment for Research Subjects: Information Sheet” to clarify that reimbursement for travel expenses to clinical trial sites and associated costs (airfare, parking, and lodging) are acceptable under current practices. The updates were made based on
Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients. The neuromodulation treatment is delivered by a hand-held unit that stimulates the vagus nerve through the skin. It was initially cleared 4/2017 for
Drugs
FDA has issued Aradigm a complete response letter (CRL) on its NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with chronic Pseudomonas aeruginosa (P. aeruginosa) lung infections. The letter says the NDA cannot be approved in its present form, and provides recommendations
FDA Policy/General
Sanofi has agreed to buy Belgium-based Ablynx for $4.8 billion. Ablynx focuses on Nanobodies, a novel class of next-generation biologics. The company has a pipeline of more than 45 proprietary and partnered drug candidates for treating hematology, inflammation, immuno-oncology and respiratory diseases. Casi Pharma has acquired