Devices
FDA has ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing the products in the U.S. An agency statement says it has determined that the products’ manufacturers—Boston Scientific and Coloplast—have not demonstrated
Drugs
FDA has granted CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating transfusion-dependent beta thalassemia (TDT). CTX001 is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. In February, CRISPR and Vertex announced that the first patient had been
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Registering with the Center for Veterinary Medicine’s Electronic Submission System — 21 CFR 11.2” (OMB Control Number 0910-0454). FDA’s electronic records/signatures regulation requires that it identify the types
Biologics
FDA has agreed that Mesoblast can submit on a rolling basis a BLA for its allogeneic cellular medicine remestemcel-L for use in children with steroid-refractory acute Graft Versus Host Disease (SR-aGVHD). Mesoblast says it will submit each BLA module on a rolling basis as it is completed.
Devices
FDA has cleared a SI-Bone 510(k) for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures. The company says that iFuse Bedrock is a technology designed to provide greater joint stabilization at the base of long spinal constructs. The device
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Luen Fook Medicine Johor, Malaysia (4/4): FDA inspected the facility 12/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have, for
FDA Policy/General
Acting FDA commissioner Ned Sharpless has reassured agency staff that the change in leadership from Scott Gottlieb to him does not reflect a desire of President Donald Trump or HHS secretary Alex Azar to have the agency go in a different direction. Speaking 4/16 at his first “all-hands”
Drugs
CDER says its statisticians are designing clinical trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative. In an online Regulatory Science Impact Story, Center officials describe the challenges involved in evaluating treatments for Ebola during the outbreak a few years ago. “A randomized
Drugs
FDA has posted a 3/14-completed Form 483 that includes nine observations from an inspection at Temple, TX-based QuVa Pharma. (XXX DELETE XXX)Agency investigators cited the firm for not having adequate written procedures to describe in sufficient detail the receipt, identification, approval, and rejection of components. The
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a revised information collection on “Tropical Disease Priority Review Vouchers” (OMB Control Number 0910-0822). The collection supports the guidance document entitled, “Guidance for Industry: Tropical Disease Priority Review Vouchers,” which explains how the agency will implement the provisions of section 524
FDA Policy/General
Federal Register notice: FDA is publishing a list of nine information collections that have been approved by OMB. They are: * Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution * Biosimilar User Fee Program * Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with
Devices
Brainlab has recalled its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent the surgeon from accurately navigating surgical tools inside the patient. Incorrect information during surgery could result in damage to a patient’s body, or a second,
Drugs
FDA has granted FibroGen an orphan drug designation for the company’s anti-connective tissue growth factor (CTGF) antibody, pamrevlumab, for treating patients with Duchenne muscular dystrophy (DMD). The designation is based on data from a Phase 2 study in 21 non-ambulatory DMD patients who have completed the first
Devices
FDA has approved an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with peripheral arterial disease. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated safety and effectiveness. The trial
Devices
FDA has cleared Gelesis’ Plenity (Gelesis100) as an aid in weight management in adults with a body mass index of 25 to 40 kg/m when used in conjunction with diet and exercise. The prescription device is administered in the form of capsules taken with water before lunch and dinner.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring — 21 CFR Parts 312 and 812” (OMB Control Number 0910-0733). The (XXX DELETE XXX)collection supports reporting and recordkeeping recommendations found in agency guidance. To view
Biologics
FDA has accepted a Novartis BLA for brolucizumab (RTH258) for treating wet age-related macular degeneration (AMD), also known as neovascular AMD. The company used a six-month priority review voucher to expedite FDA’s review. The submission is based on Phase 3 data from the HAWK and HARRIER trials.
FDA Policy/General
Regulatory Review Period for Shionogi’s Symproic Federal Register notice: FDA determines the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain. 04/12/2019 Class 2 for Ventilatory Electrical Impedance Tomograph Federal Register notice: Based on
FDA Policy/General
BIOLOGICS Baxter International has received FDA approval for Flexbumin [Albumin (Human)] USP 5% Solution. indicated for hypovolemia hypoalbuminemia due to general causes burns and in patients undergoing cardiopulmonary bypass surgery. DEVICES FDA has cleared ElMindA Ltd’s BNA Analysis System for assessing brain function in 14 to 24 year-olds.
Drugs
FDA has approved an expanded label for Merck’s Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with Stage 3 non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors
FDA Policy/General
Federal Register notice: FDA has classified suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017. The agency determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for the accessories. It made the determinations based on the risks
Drugs
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer has been convicted of conspiracy to defraud FDA and nine counts of adulterating drugs at the company’s Noblesville, IN drug compounding facility. The government charged that from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former compliance director, caused Pharmakon