Devices
TransEnterix has submitted a 510(k) for additional Senhance System instruments, including 3mm diameter instruments. TransEnterix says it is the first company to seek FDA clearance for robotically-driven 3 mm instruments for abdominal surgery in the U.S. Their clearance would allow the Senhance to be used for “scarless”
Drugs
A northern Mississippi judge 6/8 entered a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials for failing to correct promised deficiencies at the firm’s drug compounding operation. The decree prohibits Delta Pharma and the other defendants from manufacturing, processing, packing, holding or
Devices
Draeger Medical Systems begun a Class 1 recall of its Draeger Jaundice Meter due to a device design flaw. Users have misinterpreted the display for out-of-range measurement indicated by a blinking “0” to mean a zero measurement, a recall notice says. The device is intended for use in
Drugs
FDA has approved a Celixir IND for Heartcel, an immuno-modulatory progenitor (iMP) cell therapy for treating adult heart failure. The tissue-engineered product comprises allogeneic (off-the-shelf) iMP cells, which are a novel cell type engineered to reduce heart scarring and regenerate the heart in patients with heart
FDA Policy/General
FDA has approved an AbbVie’s Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Approval is based on MURANO Phase 3 clinical trial data which demonstrated
Devices
Maquet Datascope has recalled its CardioSave Hybrid Intra-aortic Balloon Pump due to a design issue that allows fluid (e.g., saline) to seep into the device. The fluid can corrode internal components (electronic circuit boards) that could lead to device malfunction and a delay or interruption of therapy, according
FDA Policy/General
Federal Register notice: FDA has published modifications to its list of standards the agency recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The publication is entitled “Modifications to the List of Recognized Standards, Recognition List Number: 049” (Recognition List Number: 049) and will assist manufacturers who elect to
Drugs
CDER director Janet Woodcock says management of the Center’s formal dispute resolution (FDR) program is being transitioned from the immediate office of the Office of New Drugs to the Office of Executive Programs. “This transition allows Center-level management of the FDR program, which is not only used by
Drugs
FDA commissioner Scott Gottlieb says that a Biotech Working Group named last month is preparing an action plan with steps the agency will take to ensure it has a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation. Gottlieb made the comment
Drugs
The HHS Office of Inspector General (OIG) says FDA computed PDUFA rates paid by drug companies accurately. An OIG audit report says the office obtained and reviewed documentation from FDA such as policies and procedures and financial records to determine whether it accurately computed prescription drug user fee rates. It
Devices
FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an advanced
Devices
A 5/24 CDRH Webinar on two precision medicine guidances outlined major changes between the 2016 draft guidances and the final documents issued 4/13. During the Webinar, Adam Berger from the CDRH precision medicine staff, said the scope of the final guidance on design, development, and analytical validation of
Drugs
The Association for Accessible Medicines (AAM) and its Biosimilars Council says FDA should take a case-by-case approach in determining whether a 505(b)(2) biological product is deemed to be a 351(a) or 351(k) biologic. AAM says this should be an administrative transition so products can
Drugs
FDA has accepted for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in this patient population. The user
Drugs
FDA has granted Ironwood Pharmaceuticals an orphan drug designation for olinciguat (IW-1701) for treating patients with sickle cell disease. Olinciguat is an orally administered soluble guanylate cyclase stimulator. The company is currently enrolling patients in STRONG-SCD, a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial
Drugs
John Jenkins, the former head of CDER’s Office of New Drugs, who left the agency following a public dust-up with Center director Janet Woodcock over approval of Sarepta’s Duchenne muscular dystrophy drug Exondys 51 (eteplirsen), is joining the board of Corbus Pharmaceuticals. Endpoints News reports that Corbus
FDA Policy/General
Federal Register notice: FDA is correcting a 2/23 notice that announced the withdrawal of 24 ANDAs from multiple applicants. That notice wrongly stated that Sun Pharmaceutical Industries asked to withdraw ANDA 077483 for benazepril hydrochloride and hydrochlorothiazide tablets, 5 mg/6.25 mg, 10 mg/12.5 mg, 20
Drugs
FDA has issued a complete response letter to Mylan and its partner Biocon on their application for a biosimilar citing Sanofi’s Lantus (insulin glargine) injection. The Center for Biosimilars reports that Mylan informed it that the letter had been expected and that the company had agreed to give the
Drugs
FDA has filed a complaint seeking a permanent injunction against Innovative BioDefense (Lake Forest, CA) and president/CEO Colette Cozean to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, methicillin-resistant staphylococcus aureus and Ebola.
Drugs
FDA has issued a guidance, Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief, to describe circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under PDUFA for some NDAs for fixed-combination and
Devices
FDA has published a draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on potential or planned medical device IDEs, PMAs, HDEs, De Novo requests, 510(
FDA Policy/General
Federal Register notice: FDA has announced a 7/25 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a GlaxoSmithKline supplemental BLA for mepolizumab for injection and its use as as add-on treatment for inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic