Devices
FDA is joining the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services to launch a tri-agency task force to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public
Drugs
FDA has approved a Romeg Therapeutics 505(b)(2) NDA for Gloperba (colchicine) Oral solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults. Gloperba is the first liquid formulation of colchicine approved by FDA for this indication. “Existing therapies do not adequately address the physician’s
Drugs
In a decision that may ultimately affect FDA as well, the 3rd Circuit Court of Appeals has issued a ruling in FTC v. Shire ViroPharma that attorney Jennifer Thomas (Hyman, Phelps & McNamara) says “could set the Federal Trade Commission’s litigation authority back decades.” Writing in her firm’s
Drugs
FDA has released the FDA-483 issued following a 1/7-1/15 inspection at the Dr. Reddy’s Laboratories facility in Andhra, Pradesh, India. The four inspection observations in the report were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Devices
FDA has cleared a Sensus Healthcare 510(k) for the Sculptura radiation oncology system, a single radiation treatment used during cancer surgery. The robotic intraoperative radiation therapy system uses patented Beam Sculpting capabilities to treat various cancers during surgery. The first device has been installed at the University of Pennsylvania&
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Pure Source Doral, FL (2/20): FDA inspected the firm 2/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Pure Source failed to thoroughly investigate an
Drugs
Pharmaceutical Manufacturing Research Services chief executive Ed Thompson told CBS’s 60 Minutes 2/24 that FDA ignited the current opioid crisis when in 2001, and pressured by Big Pharma, the agency wrongly approved a label expansion for Purdue Pharma’s Oxycontin to be used for chronic, long-term pain
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Devices
FDA has issued a Warning Letter to Total Thermal Imaging (La Mesa, CA) for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases. The agency also issued a safety communication to warn patients that thermography is not cleared as an
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation — Nonclinical Testing and Clinical Considerations.” The document defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/15/2018 proposed rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” Electronic or written comments should be submitted by 3/7. To view the notice, click here.
Devices
FDA has cleared an Alphatec Holdings 510(k) for the SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessments during spinal surgery. The company describes the device’s next-generation technology advances as two intraoperative neurophysiological monitoring modalities: somatosensory evoked potential (SSEP), and electromyography (EMG)
Drugs
FDA has published two draft guidances to help drug developers get agency approval. The first draft guidance, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs,
Drugs
FDA has approved a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil) for treating adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy. Approval was based on data from the global, randomized, Phase 3 TAGS trial evaluating Lonsurf plus best
Devices
FDA has cleared a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients’ breath. FeNO is an established biomarker for airway inflammation in human exhaled breath,
Drugs
Macleods Pharmaceuticals has recalled one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern. The recall is due to unacceptable amounts of N-nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited. Last month, an updated FDA
Drugs
A new FDA safety alert warns patients and healthcare professionals about Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) after a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of the drug was used in patients with rheumatoid
FDA Policy/General
Draft Guide on Nicotine Replacement Drug Products Federal Register notice: FDA makes available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” 02/22/2019 Rule on Bulk Drug Substances for Compounding Federal Register notice: FDA issues a final rule to establish criteria for
FDA Policy/General
BIOLOGICS FDA has approved a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults
Devices
FDA has released a draft guidance entitled “Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.” The document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices. The scope of this document is limited to
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug etoposide toniribate, described as a novel topoisomerase II inhibitor intended for treating relapsed refractory biliary tract cancer. Also known as cholangiocarcinoma, biliary tract cancer is a rare disease that starts in the bile ducts. It is the
Drugs
FDA has accepted for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies. The submission is supported by data from the PREVENT study in patients with anti-AQP4 auto antibody-