Devices
Attorney John Sullivan, writing in a Drug & Device Law blog post, praises a Minnesota state court decision that all claims in a suit against Medtronic are preempted by federal regulations. The case involved allegations that the plaintiff had complications from a pain pump implant. The suit alleged a number
FDA Policy/General
Federal Register Notice: FDA seeks comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. Comments should be submitted by 8/8. To view notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Alprolix is 2,223 days for extending patents which claim the human biological product. Alprolix is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for controlling
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Eloctate is 1,695 days for extending patents which claim the human biological product. Eloctate is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency)
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee 7/26 from 1 p.m. to 3:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD.
Drugs
A Northern California federal judge has tossed out a Merck $200 million jury verdict against Gilead Sciences after finding misconduct by the company and one of its expert witnesses. The case, Gilead Sciences v. Merck & Co., involved assertions by Merck that two of its patents cover sofosbuvir, and that
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during March and April. These are Elanco Animal Health’s Imprestor, Aratana Therapeutics’ Galliprant, and Eco’s Aivlosin mediated article. The agency is also informing the public of the availability
Drugs
FDA has granted Remedy Pharmaceuticals a fast track designation for its investigational drug Cirara and its use in treating large hemispheric infarctions (LHI). The company is planning a Phase 3 trial called CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) in patients with LHI, a disease associated
Devices
Reps. Michael Fitzpatrick (R-PA) and Louise Slaughter (D-NY) have introduced two bills to improve medical device safety and allow those harmed by devices to seek legal recourse. Fitzpatrick has been an outspoken advocate for FDA and medical device reform and continues to call for an Energy & Commerce
Devices
A 11/30-15-1/21/16 FDA inspection at Spectranetics Corp., Colorado Springs, CO, found Quality System Regulation and other violations in the firm’s manufacturing of lead management disposable catheter lines, including laser sheath device products, specifically the GlideLight and SLS II sheaths. A 5/23 Warning Letter
Drugs
Sarepta Therapeutics and its eteplirsen for treating Duchenne muscular dystrophy received a shot in the arm 6/6 when, in an apparent compromise with FDA, the company agreed to an agency request that it provide dystrophin data, as measured by western blot, from biopsies already obtained from an ongoing confirmatory
Drugs
With the number of shipments of FDA-regulated products into the U.S. more than doubling from 15 million to more than 34 million in the past decade, the agency is implementing initiatives to keep pace, according to deputy commissioner for global regulatory operations and policy Howard Sklamberg. Writing in
Drugs
A 5/25-27/15 FDA inspection at Ko Da Pharmaceutical Co., Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/27 Warning Letter. Specific violations noted include: * failure of the firm’s quality unit to approve or reject
Drugs
An FDA Office of Criminal Investigations case has led to a guilty verdict against Chenhsin Chan, also known as Paul Chan, in connection with his online marketing and sale of dietary supplements containing ephedrine in violation of a federal ban. Chan was found guilty in the Northern District of Georgia
Drugs
AstraZeneca is petitioning FDA to not approve any ANDA or 505(b)(2) NDA referencing its Crestor (rosuvastatin calcium) until expiration of the orphan drug exclusivity for using the drug to treat pediatric patients ages 7 to 17 with homozygous familial hypercholesterolemia (HoFH) The petition says that pediatric HoFH is
Drugs
A letter from 28 organizations, including Friends of Cancer Research, to FDA commissioner Robert Califf urges the agency to create an FDA Oncology Center of Excellence, providing detailed recommendations as to how this program could be implemented. The proposal asks the agency to “refocus resources” based on specific diseases to
Devices
FDA has cleared a MOOE Orthopedics 510(k) for the DynaMOE Nitinol Compression Screw. The device “utilizes the superelastic properties of nitinol to provide higher levels of compression than contemporary bone screws,” according to the company. “During manufacturing, the dynaMOE Nitinol Compression Screw is stretched and held in an elongated
Drugs
Commenting on the 5/3-5/4 joint meeting of FDA’s Drug Safety and Risk Management Advisory Committee and Analgesic Drug Products Advisory Committee, which discussed possible changes to REMS (Risk Evaluation and Mitigation Strategies) for extended release/long acting (ER/LA) opioid analgesics, the American Pharmacists’ Association said
Drugs
FDA has issued a drug safety alert to warn that taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium) can cause serious heart problems that can lead to death. “The risk of these serious heart problems, including abnormal heart rhythms, may also
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Forms FDA 3486 and 3486A. Comments should be submitted by 8/8. To
FDA Policy/General
The Mid-Year Update for the 2016 HHS Inspection General (OIG) work plan includes two new FDA studies — one to review prescription drug user fees and one to review networked medical device cybersecurity during the device approval process. Both study reports are expected to be issued in FY 2017. The
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. 86 Harriet Ave. Corp. dba General Devices Ridgefield, NJ (6/1). Inspected 6/2/15-6/11/15. QSR deviations, adulterated: The firm failed to adequately establish procedures for