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
Devices
FDA has cleared a Lumendi 510(k) for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. “Adequate tissue manipulation and traction, combined with effective cutting, dissecting and cauterizing, continues to be
Drugs
A 10/31-11/3/17 FDA inspection at Europharma Concepts, County Offaly, Ireland, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/16 Warning Letter. Specific violations cited in the letter were: * failing to test samples of each component for conformity
Devices
Attorneys Gregory Levine and Abram Barth (Ropes & Gray) say that an FDA 4/27 draft guidance “provides insight into how FDA conceives of its authority to regulate multiple function devices consistent with the 21st Century Cures Act.” They say the document may be useful not only for manufacturers of
Devices
FDA is reminding healthcare professionals involved in surgical procedures about the risk of surgical fires on or near patients. The agency safety notice includes recommended practices to reduce fires from occurring, including the safe use of medical devices and products commonly used during surgical procedures. The notice says that although
Drugs
FDA has issued a guidance, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, to assist sponsors in clinical development of drugs to treat complicated intra-abdominal infections (cIAI). The document specifically addresses the agency’s thinking on the overall development program and clinical trial designs for drugs to support an
Devices
FDA has opened a docket to receive feedback from stakeholders on provisions of the 21st Century Cures Act that exclude certain medical software functions from the definition of a medical device. Under that law, the agency says, Congress excluded specific types of software from FDA regulation, including general wellness software
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Europharma Concepts Clara Tullamore, Ireland (5/16): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to test samples
FDA Policy/General
Guide on Anthrax Prevention Drugs Federal Register notice: FDA makes available a guidance entitled ‘‘Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.’’ 05/24/2018 Comments Sought on Study Design for Heartworm Drugs Federal Register notice: FDA seeks comments as it evaluates current thinking about the design of studies intended
Drugs
DEVICES FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on
Drugs
FDA has approved a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria (PKU), a rare and serious genetic disease where patients are born with an inability to break down phenylalanine, present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages.
Devices
FDA has cleared a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the peripheral arterials. The company says this allows physicians to select between both of XableCath’s designs (blunt or abrasion tips) to slide past an occluding
Devices
FDA has granted Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to locate wrist fractures in adult patients. The software uses an artificial intelligence algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture, a common
Drugs
FDA has granted Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa (DEB). The company says that KB103 is the first topically-applied herpes simplex virus based gene therapy engineered to deliver a human collagen protein to patients suffering from DEB, which is a chronic and