Devices
CDRH is planning to establish a centralized digital health unit within the Office of the Center Director to ensure “proper coordination and consistency across the agency” for device-related apps and “software as a medical device (SaMD) issues.” Speaking last week at MedCon conference at Xavier University, CDRH associate director
Drugs
FDA has granted Oncolytics Biotech a fast track designation for Reolysin, an immuno-oncology viral agent for treating metastatic breast cancer. Last month, the company reported Phase 2 data from an open-label, randomized study assessing the therapeutic combination of intravenously-administered Reolysin given in combination with paclitaxel versus paclitaxel
Devices
FDA has cleared a Medrobotics 510(k) for the Flex Robotic System and its use for colorectal procedures. The company describes the flexible device as the world’s first robotic surgical platform to offer “scar-free” access to hard-to-reach anatomy in otolaryngology and colorectal procedures. Traditional surgical robots
Drugs
FDA has sent TherapeuticsMD a complete response letter (CRL) on its NDA for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause. The agency’s letter raised concern
Drugs
FDA has cleared a CurveBeam 510(k) for InReach, a cone beam computed tomography imaging system designed for the hand, wrist, elbow and lower extremities in non-weight bearing position. The device provides high-contrast 3D datasets of bony anatomy, which could potentially replace radiographs as a first line diagnosis,
FDA Policy/General
Pediatric Panels to Review Duchenne Trial Protocol 05/02/2017 Federal Register notice: FDA announces a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an Institutional Review Board of a clinical investigation that involves children with Duchenne muscular dystrophy. FDA Seeks Comments
Devices
Medtronic Mechanical Circulatory Support has expanded a Class 1 recall of its Ventricular Assist Device Controllers and DC Adapter to now include all controllers. The device helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from
Drugs
FDA has cleared a Crospon 510(k) for its Endoflip System with Flip Topography Module, which is intended to assess patient motility disorders during endoscopy. The device features imaging software that displays real-time esophageal contractility patterns on a 24-in. touch-screen. “The unique repetitive visual cues of the
FDA Policy/General
FDA is seeking comments from its Science Board on a draft work plan on 21st Century Cures Act Innovation Account Activities that prioritizes patient-focused drug development and qualification of drug development tools when monies are appropriated by Congress. The draft discusses how FDA is required under Cures to establish
Drugs
Growth in U.S. spending on prescription drugs dropped last year as competition between manufacturers heated up and payers stepped up efforts to curb price increases, according to QuintilesIMS Institute’s annual report, Medicines Use and Spending in the U.S. – A Review of 2016 and Outlook to 2021. It
Drugs
FDA has approved a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day
FDA Policy/General
FDA reportedly has been ordered to replace CNN with Fox News broadcasts on internal video monitors across its White Oak, MD campus, but the agency is denying the allegation and indicated that various news channels are broadcasting in common areas around campus. Apparently, a screenshot of an internal FDA email
Drugs
FDA has posted a Dr. Reddy’s Laboratories Form 483 from a 4/28 inspection that cited the firm’s Bachupally, Hyderabad, India manufacturing facility on 11 observations. The agency said the firm’s lab controls do not include scientifically sound and appropriate sampling plans. It also found that the
Drugs
The 10th Circuit Court of Appeals has remanded to a Utah federal court portions of a failure-to-warn case brought against Aventis over its fertility drug Clomid (clomiphene citrate). The Utah court had granted summary judgment to Aventis on the failure-to-warn, breach of implied warranty, negligent misrepresentation,
Devices
FDA has approved a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems. The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company recalled last month. The company anticipates replacing all recalled
Drugs
FDA has granted Altor BioScience a fast track designation for its investigational interleukin-15 (IL-15) agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for treating patients with non-muscle invasive bladder cancer (NMIBC). ALT-803 is currently being studied in a Phase 1b/2 clinical trial
Drugs
The Biosimilars Forum has urged FDA to be more flexible with its approach in determining a proposed biosimilar product’s interchangeability with an innovator’s product. In comments addressing the agency’s recent draft guidance on Considerations for Demonstrating Interchangeability with a Reference Product, the organization urges FDA to consider,
Drugs
India’s LiveMint online media reports that Wockhardt posted a bigger loss in the first quarter of this year due to expenses for remedial measures at plants facing regulatory issues. “Wockhardt has been grappling with quality control issues raised by the U.S. FDA for the past four years,” the
Devices
FDA says that the Medtronic 3/16 recall of all HeartWare Ventricular Assist System pump driveline spice kits distributed between 1/11/11 and 5/23/14 and used before 4/2015 is a Class 1 recall. An agency notice says that the device helps deliver blood from the heart
Drugs
FDA has granted rare pediatric disease designation for Sangamo Therapeutics’ SB-913 in vivo genome editing treatment for mucopolysaccharidosis type 2 (MPS 2). It also gave orphan drug designation to the company’s SB-525 cDNA therapy for hemophilia A, and fast-track designation for SB-FIX in vivo genome
Drugs
Apotex is petitioning FDA to issue specified requirements for biosimilar applicants referencing Amgen’s Neulasta (pegfilgrastim). Specifically, the petition asks that FDA: * require all biosimilar applicants referencing Neulasta demonstrate “no clinical meaningful differences” by conducting a comparative clinical efficacy study in at least one of Neulasta’s indicated patient populations;
Devices
FDA has cleared an Interscope 510(k) for the EndoRotor System for use in gastroenterology and colorectal surgery. The device is intended for removing alimentary tract mucosa during colonoscopy. It resects and removes tissue simultaneously through a catheter inserted into the working channel of an endoscope. “Clinical data shows that