Drugs
FDA says it wants to take steps to clarify the information the agency requires to better inform it about the extent of a drug shortage problem. In a statement, FDA commissioner Scott Gottlieb says the agency also is looking at what additional steps can be taken under existing law to
Devices
FDA has approved a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The low-profile visualized intraluminal support device features a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to support the
Drugs
Nektar Therapeutics has submitted an NDA for NKTR-181, an analgesic opioid molecule that the company says exhibits a reduced incidence of specific side effects, such as euphoria, through the targeted alteration of brain-entry kinetics. The submission is supported by clinical data from 15 studies in 2,234 subjects,
Drugs
FDA has made available an International Council for Harmonization draft guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex” that provides examples of how to identify established conditions for drug manufacturing processes. The examples describe the relevant reporting categories for changes to the ranges of the
Drugs
FDA has granted Genea Biocells an orphan drug designation for GBC0905 and its use in treating facioscapulohumeral muscular dystrophy (FSHD). The company says the small molecule agent works by suppressing DUX4 function, the molecular cause of the disease. It says FSHD is one of the most common muscular dystrophies and
Drugs
FDA has issued a draft guidance, Assessment of Pressor Effects of Drugs, to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. The document is intended to address precision of blood pressure measurements when assessing the effects of a drug in development. It recommends systemic
Drugs
FDA has published an International Conference on Harmonization draft guidance, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, that “provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner.” The document also is intended to demonstrate how increased product
Devices
FDA has published a draft guidance, Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions, to describe relevant information that the agency wants included in complete test reports for non-clinical bench performance testing provided in a pre-market submission (PMA, HDE,
Devices
FDA has released the FDA-483 issued following a 4/9-4/24 inspection at Zimmer Biomet, Warsaw, IN. The 11 inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately validate according to established procedures a process whose results cannot be fully verified
Devices
FDA has cleared a Neural Analytics 510(k) for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of its ultrasound products under the guidance of a healthcare professional. When used with its previously cleared Lucid M1 Transcranial Doppler Ultrasound System, the device is intended to
Drugs
FDA has expanded the approval of Pfizer’s Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis, the first oral drug approved for chronic use in this indication. Other treatments must be administered through an intravenous infusion or subcutaneous injection, according to an agency release. Expanded approval
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The document is intended to assist sponsors in determining when a DMC is needed for monitoring a study and how such committees
Drugs
FDA has approved a TherapeuticsMD NDA resubmission for Imvexxy (estradiol vaginal inserts) for treating moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, due to menopause. FDA 5/2017 rejected an earlier submission, raising concern about a lack of long-term endometrial
Devices
FDA has approved HumanOptics’ CustomFlex artificial iris, the first standalone prosthetic iris in the U.S. An agency news release says the surgically implanted device treats adults and children whose iris is completely missing or damaged due to aniridia or other damage to the eye. The CustomFlex product is made
Drugs
FDA has placed a clinical hold on a CRISPR Therapeutics and Vertex Pharmaceuticals trial of CTX001 for treating sickle cell disease pending the resolution of certain questions that the agency presented as part of its IND review. The IND was submitted in April to support the planned initiation of a
Devices
FDA has started an “innovation challenge” to encourage development of medical devices, including digital health technologies and diagnostic tests, that could provide novel solutions to detecting, treating, and preventing addiction, addressing diversion, and treating pain. Companies selected by the agency to participate in the challenge will have an opportunity for
Devices
FDA has cleared a BrainCool 510(k) for the IQool Warm System, intended for use to provide thermal regulation to cool and rewarm adult patients when clinically indicated. The company says the device adds a new feature to its 2017 originally cleared device — to cool patients using its anatomically targeted
Drugs
A 12/11-12/13/17 FDA inspection at Jalco Cosmetics, Silverwater, NSW, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/18 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
Drugs
An 11/7-11/10/17 FDA inspection at Jilin Shulan Synthetic Pharmaceutical Co., Shulan City, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to a 5/14 Warning Letter. Specific deviations cited in the letter were: * failing to document known deviations and
Drugs
FDA has accepted for priority review an Astellas Pharma NDA for gilteritinib for treating adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. “FLT3 mutations impact approximately 30 percent of AML patients and are
Drugs
FDA has issued an online communication to clarify the submission process for expedited serious adverse event (SAE) safety reports from premarket bioavailability/bioequivalence (BA/BE) studies conducted to support development of an ANDA. The document says that companies with premarket SAE reports from BA/BE studies conducted in the U.
Drugs
FDA has granted Pfizer a Breakthrough Therapy designation for Xalkori (crizotinib) for treating patients with metastatic non-small cell lung cancer (NSCLC) who have MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The agency also granted a Breakthrough Therapy designation for the therapy and its