Drugs
FDA has approved Astellas Pharma’s Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The agency also approved an expanded indication for a companion diagnostic, Invivoscribe Technologies’ LeukoStrat CDx FLT3 Mutation
Drugs
FDA has granted six months pediatric exclusivity to Pfizer’s Lyrica (pregabalin). The grant extends the Lyrica market exclusivity period to 6/30/19. The company says Lyrica is currently approved in the U.S. for treating fibromyalgia, diabetic nerve pain, spinal cord injury pain, and pain after shingles in
Devices
FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway. The document describes study designs for generating data that support both 510(k) clearance and CLIA waiver. The
FDA Policy/General
Federal Register notice: FDA has announced a 4/10/2019 public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting and comment opportunity is intended to fulfill FDA’s commitment to seek stakeholder input on data standards and the electronic submission system’s
Drugs
Hyman, Phelps & McNamara is asking FDA not to approve any sNDA to allow Zelnorm (tegaserod maleate) to be marketed unless the sNDA contains substantial evidence of safety and effectiveness for the proposed use in the proposed population under current applicable standards. In the alternative, an 11/21 petition says,
Drugs
Synaptive Medical has recalled its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially result in serious or life-threatening patient harm. An FDA recall notice says that when the device is used with a specific third-party port (the NICO BrainPath device), a software defect
Drugs
The International Council for Harmonization (ICH) approved concept papers and business plans for three new informal working groups and a new discussion group at the ICH meeting 11/10-11/15 in Charlotte, NC. A media release on the meeting says the new working groups are on analytical procedure development,
Devices
FDA has cleared a Mesa Biotech 510(k) for its Accula RSV test, a respiratory syncytial test cassette for diagnosing both children and adult populations. The Accula RSV test is the second molecular point-of-care diagnostic on the Accula platform to receive FDA clearance and follows the company’s
Devices
FDA has classified as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and the SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator due to a lack of adequate validation and controls to ensure
Drugs
FDA has approved Bayer and Loxo Oncology’s Vitrakvi (larotrectinib) for treating adult and pediatric cancers in patients who have a specific genetic feature (biomarker). The accelerated approval drug is indicated for treating patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known
Devices
Former FDA associate commissioner Peter Lurie, who now heads the Center for Science in the Public Interest, is expressing concern that with its emphasis on being “first” in medical device approvals and acting on safety signals, FDA is laying the groundwork for a “sliding scale” of medical evidence that will
Drugs
FDA says it is reducing the minimum measles antibody potency specification for immune globulin (IG) products in response to declining titers of measles antibodies in plasma donors. In a letter to licensed IG manufacturers, the agency says that declining levels of measles antibodies in plasma are caused by a decrease
Drugs
A Goldwater Institute investigative report, “Studied to Death: FDA Overcaution Brings Deadly Consequences,” says the result of an FDA fear that regulators might miss something and be subject to congressional and media criticism is “more preventable deaths and more diseases that go untreated because of a regulatory system that emphasizes
Devices
FDA has declined a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musculoskeletal pain. “In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. The Delano Co., dba LifeLink Grover Beach, CA (9/7): FDA inspected the firm in April, and after a subsequent review of product labels and statements contained on company
Drugs
Pfizer says an FDA draft guidance is less clear and helpful than a previous guidance on the same topic. In addition, the comment letter says, there are assumptions and general comments throughout the guidance that likely will be rendered incorrect by case-by-case science and program understanding. “Thus,” it
Drugs
A 3/19-4/12 FDA inspection at the Mylan drug manufacturing facility in Morgantown, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/9 Warning Letter identifies the violations as: * failing to clean, maintain, and, as appropriate for the nature of the
Drugs
FDA has placed a clinical hold on a Zafgen clinical trial of ZGN-1061, the company’s second-generation, investigational MetAP2 inhibitor currently in development for treating Type 2 diabetes. The agency cited the possibility of cardiovascular (CV) safety risk based on the company’s prior compound and outlined multiple
Devices
FDA has released a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/2017 Patient Engagement Advisory Committee meeting. The agency notes that device clinical trials designed with patient input may be more likely to enroll and retain patients, collect
Devices
FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve device safety or performance and to “retire” outdated predicate devices that have been cited to demonstrate equivalence, “especially in cases where we’ve seen
Drugs
FDA has issued a Form FDA-483 after an August inspection of a Cantrell Drug Co. outsourcing facility in Little Rock, AR. According to the FDA-483, buildings used in manufacturing, processing, packing, or holding of drug products did not have the suitable construction to facilitate cleaning, maintenance, and proper
Drugs
FDA has approved Genentech’s ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, and