Devices
Abbott has begun a recall of specific lots of three catheters — NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. A recall notice says that affected products could cause difficulty when the protective balloon sheath is removed, which in turn could
Devices
A 3/28-4/7 FDA inspection at Oxford Performance Materials, South Windsor, CT, found Quality System Regulation violations in the firm’s manufacturing of Osteofab 3D-printed cranial and maxillofacial implants, according to a 5/1 Warning Letter from the agency’s New England District Office. Specific violations documented
Devices
A 1/3-1/12 FDA inspection at Vidco, Inc., Beaverton, OR, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of patient monitoring devices including the NetViewer MDP2040-0100 device, according to a 5/5 Warning Letter from the agency’s Seattle District Office.
Drugs
A 10/24-11/1/16 FDA inspection at Vertical Pharmaceuticals, Bridgewater, NJ, found “serious violations” of Postmarketing Adverse Drug Experience reporting requirements, according to a 5/10 Warning Letter from the agency’s New Jersey District Office. Specific violations listed on an FDA-483 included: * failing to develop written
Biologics
FDA has granted Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA (cDNA) gene therapy candidate for hemophilia A, which is being developed as part of a collaboration and license agreement with Pfizer. SB-525 uses a recombinant adeno-associated virus to deliver a human
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Howard Phillips, LLC Millerton, OK (5/8): FDA inspected the firm 10/2016 and documented significant GMP violations involving finished pharmaceuticals. For example, FDA said the firm does not
Drugs
FDA has approved a Pharmadax ANDA for a generic copy of Seroquel XR (quetiapine fumarate) extended release tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. Pharmadax has launched the product with their marketing partner TruPharma LLC. Seroquel XR is a once-daily tablet indicated for treating
Drugs
Enforcement officials are closely scrutinizing drug and medical company speaker programs for False Claims Act violations. Attorney Matthew Curley (Bass, Berry & Sims) writes in an online blog post that drug and device manufacturers accounted for nearly half of the enforcement recoveries from the healthcare industry last year. Curley says
Drugs
Eleven Democratic senators have written to President Donald Trump expressing concern about the impact of his proposed budget cuts and workforce reductions for the Department of Health and Human Services on implementation of the bipartisan 21st Century Cures Act. The 5/16 letter says that in the bill “Republicans and
Drugs
The CDER Office of Generic Drugs says that 21 product-specific guidances for generic drug development were added since 5/1. Products covered by the guidances are acetcylsteine; amphetamine; aprepitant; azelastine HCl; biscodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride; carbidopa, levodopa; chlordiazepoxide HCl, clidinium bromide; clonazepam; edoxaban
Drugs
FDA says data from two large clinical trials indicate that canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) causes an increased risk of leg and foot amputations. An agency drug safety communication says that a Boxed Warning will be added to the drugs’ labeling describing the
Devices
FDA has approved an Alucent Medical Phase 1 clinical trial of Natural Vascular Scaffolding (NVS), a novel combination drug/device therapy for treating peripheral vascular disease. The current standard of care for peripheral vascular disease relies on percutaneous balloon angioplasty, in which balloons are coated with known antiproliferative drugs such
Drugs
Ionis Pharmaceuticals says that primary endpoints were met in its Phase 3 NEURO-TTR study of Ionis-TTR (inotersen) in patients with familial amyloid polyneuropathy. “Over the 15-month period of the study, inotersen-treated patients achieved statistically significant benefit compared to placebo in the modified Neuropathy Impairment Score +7
FDA Policy/General
Federal Register notice: FDA has requested comments related to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The agency says it is seeking insight regarding the development and overall design/approach of the pilot program including program goals, pilot standards, design concepts, and overall program approach. Voluntary consensus standards
Drugs
FDA has granted Imara a rare pediatric disease designation for IMR-687, the company’s lead product candidate for treating sickle cell disease. The company is conducting a Phase 1a clinical study to evaluate the safety and pharmacokinetics of IMR-687 in healthy volunteers. In addition, it will assess pharmacodynamic
Drugs
FDA has accepted for review an Aerie Pharmaceuticals NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, indicated for treating elevated intraocular pressure (IOP) in glaucoma. The agency has set a user fee review target date of 2/28/2018, and it has told the firm to expect an advisory committee
Drugs
CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application, and there was only one instance where safety events under expanded access had a potentially negative effect on product labeling. “Concern that expanded access will have a negative impact on drug development
Drugs
FDA has issued a Form 483 to Badrivishal Chemicals & Pharmaceuticals (Maharashtra, India) related to a 8/2016 facility inspection that cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators found that the firm’s water purification system was not adequately monitored and controlled. Additionally,
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance for industry on “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.” The document is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution
Drugs
Senators Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) have urged the Trump Administration to use existing executive authority to lower prescription drug costs, including a certification to allow importation of prescription drugs from Canada. The three have worked together on bipartisan legislation to allow
Drugs
Eli Lilly says it will file a BLA in the second half of this year after reporting positive Phase 3 data for galcanezumab, an investigational treatment for preventing episodic and chronic migraines. Three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrated “statistically significant reductions in the number of
Devices
FDA has cleared a Quidel 510(k) to market its Solana C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens from patients suspected of having such an infection. Unlike traditional methods for diagnosing C. difficile, such as glutamate dehydrogenase or toxin antigen