Drugs
FDA has extended its review of a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy. The submission has become a politically charged issue, with U.S. lawmakers weighing in and urging the agency to exercise its flexibilities when making a review decision. The agency notified
Drugs
Relypsa has submitted a supplemental NDA requesting label changes for Veltassa (patiromer) for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers. Veltassa was approved in 2015 for treating hyperkalemia. The drug-drug interaction program submitted as part of Veltassa’s original NDA
Drugs
FDA has granted Viamet Pharmaceuticals an orphan drug designation for VT-1598 for treating coccidioidomycosis (also known as Valley Fever). VT-1598 is a selective, orally available inhibitor of fungal CYP51 that the company says has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for
Drugs
A 5/4-7/15 FDA inspection at the BBT Biotech Gmbh drug manufacturing facility in Baesweiler, Germany, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/16 Warning Letter says that specific deviations included: * failing to follow a documented, on-going stability testing
Devices
A 1/19-2/5 FDA inspection at the Germantown, MD, manufacturing facility operated by Germany’s Qiagen found multiple violations in the firm’s manufacturing of the QuantiFERON-TB Gold test device, according to a 5/16 Warning Letter. Violations listed on an FDA-483 included: * procedures for corrective
Devices
Alcon has recalled its Ophthalmic Valved Trocar Cannula (23G and 25G) because the devices have the potential to leak beyond their design specification. They provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy surgeries, according to an
Drugs
FDA has approved a Janssen Pharmaceuticals NDA supplement for Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) and metformin hydrochloride, for treating first-line adults with Type 2 diabetes. With this approval, Invokamet may now be marketed for use in adults with Type 2 diabetes who are not already
Drugs
FDA has accepted for review an Allergan NDA for oxymetazoline HCl cream 1.0% for treating persistent facial erythema (redness) associated with rosacea in adults. The company expects a user fee target date in first half of 2017. Oxymetazoline is a sympathomimetic agonist that is selective for the a1A-adrenoceptor
Devices
FDA has cleared a Perimeter Medical Imaging 510(k) for its OTIS 1.0 Optical Coherence Tomography System. The company says the device provides “high-resolution, real-time imaging of the periphery of excised tissue, enabling clinicians to visualize sub-surface structures up to 2 mm below the surface. These
FDA Policy/General
The Senate Health, Education, Labor and Pensions (HELP) Committee should observe “regular order” and not tack on any new amendments as FDA reform and medical innovation bills recently approved by the committee are combined into one legislative package, according to a letter by 13 healthcare groups. Last month, the HELP
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Banner Pharmacy Services, LLC Phoenix, AZ (5/5). Inspected Chandler, AZ facility 3/16/15-3/2015. Violations, adulterated, misbranded, unapproved new drugs: The investigators noted that the facility
Drugs
University of California-San Diego emeritus professor Daniel Kripke is suing FDA for not adequately regulating sleeping pills. Courthouse News Service reports that Kripke’s suit says that sleeping pills are among the more prescribed drugs in the country and “are the immediate cause of death of more than 10,
Drugs
A 5/4-11/15 FDA inspection at Tai Heng Industry, Shanghai, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to a 5/12 Warning Letter. Specific deviations observed included: * failing to adequately investigate out-of-specification results and implement appropriate corrective actions;
Drugs
Saying that drug manufacturers too often are ignoring informal FDA communications stating that the agency does not require submission of in vivo rabbit ocular and skin irritation tests (Draize), the Center for Responsible Science (CRS) is asking the agency to issue guidance “communicating broadly that FDA will accept in vitro
Drugs
A whistleblower who claimed that Pfizer induced false claims for its Lipitor because it marketed the drug as appropriate for patients whose risk factors and cholesterol levels are outside the National Cholesterol Education Program guidelines, has lost an appeal to the 2nd Circuit Court of Appeals. Dr. Jesse Polansky, who
Devices
CDRH has posted a learning module on early feasibility studies to help sponsors develop an IDE plan. Such early studies are designed for about 15 subjects, according to the Center, using a device design that is early in development. The studies generally provide initial clinical insights when additional nonclinical studies
FDA Policy/General
Federal Register Proposed rule: FDA is extending the comment period for a 4/25 proposed rule in which the agency requested comments for a ban on electrical stimulation devices used for self-injurious or aggressive behavior. Comments should be submitted by 7/25. To view this notice, click here.
Devices
The latest medical device user fee proposal from FDA would cost $329 million more than the current user fee program, according to just-released user fee negotiation meeting minutes. FDA said the proposal addresses key innovation initiatives that are important to patient and consumer groups, such as patient input, real
Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB2, a biosimilar candidate referencing Janssen’s Remicade (infliximab) for treating rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the U.S. If
Drugs
FDA has cleared an Avantis Medical Systems 510(k) for the Third Eye Panoramic device for use as a multi-use imaging product for colonoscopies. Previously cleared as a disposable device, the new clearance now allows the device to be marketed for use multiple times prior to disposal. Avantis Medical
Devices
FDA has cleared an EndoChoice Holdings 510(k) for the Orca sterile, single-use air/water and suction valves for Olympus 160, 180 and 190 Series flexible endoscopes. The company says the device is designed to eliminate the need to clean and disinfect reusable valves. It adheres to recently published
Devices
FDA should require more rigorous clinical studies for high-risk medical devices used in obstetrics and gynecology than currently required, according to researchers from Northwestern University. Their study, published in the journal Obstetrics and Gynecology, found that some high-risk devices were approved based on flawed data. “We found that