Devices
FDA has cleared an Advanced Cooling Therapy 510(k) for the Esophageal Cooling Device for modulating and controlling patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. “Two lumens attach to existing temperature modulation equipment while a third lumen
Drugs
The U.S. Supreme Court has rejected an appeal from Johnson & Johnson over a $63 million judgment awarded to a family whose daughter developed toxic epidermal necrolysis (TEN) after being given multiple doses of Children’s Motrin. The parents argued that the company should have acted unilaterally to change
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may
FDA Policy/General
Federal Register Notice: FDA is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee notify the agency in writing. It is also requesting nominations for voting industry representatives to serve on the committee.
Drugs
FDA investigators found multiple violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in a 7/6-7/8/15 inspection at Chan Yat Hing Medicine Factory, Kowloon, Hong Kong, according to a just-released 12/15/15 Warning Letter. The letter says the firm did not respond
Devices
FDA director of emergency preparedness, operations, and medical countermeasures Suzanne Schwartz says the agency wants medical device manufacturers and healthcare delivery organizations to incorporate threat monitoring, cyber hygiene for better prevention of attacks, and active responses to identified vulnerabilities. In an online interview with Healthcare IT News, Schwartz says those
FDA Policy/General
Attorneys Sheila Boston and Candice Andalia (Kaye Scholer) say that drug and medical device companies should closely follow the evolving FDA regulatory landscape affecting company use of social media. Writing in an online blog post, they review the agency’s regulatory actions taken through Warning Letters, untitled letters, and draft
Biologics
FDA has promoted CBER deputy director Peter Marks to director of the office effective 1/1. Marks replaces Karen Midthun, who retired after 22 years of FDA service in December. Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. He completed
Drugs
Abbott’s Compounding Pharmacy has recalled all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. Affected products include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California. The recall
Biologics
The U.S. Patent and Trademark Office (PTO) has denied two Amgen petitions that sought to review two formulation patents on AbbVie’s rheumatoid arthritis therapy Humira. The PTO rejection is seen as a potential roadblock in Amgen’s move to gain FDA approval for a biosimilar version of Humira.
Drugs
Six Skadden Arps Slate Meagher & Flom attorneys say the Justice Department appears to be moving away from enforcement actions against off-label promotion practices and toward the financial and commercial relationships between healthcare providers and companies. Writing in an online blog post, the attorneys says that in 2016 they
FDA Policy/General
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/15-16, from 8 a.m. to 6 p.m. at Holiday Inn Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. On 3/15, the committee will discuss an Abbott Vascular PMA
FDA Policy/General
Federal Register Notice: FDA’s Arthritis Advisory Committee will meet 2/9, from 7:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Celltrion BLA for
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alkebulan International Services, LLC Hampton, VA (1/13). Inspected /6-17/15. CGMP deviations, adulterated, unapproved new drugs: The therapeutic claims on the firm’s Web site and on
Devices
A class action suit filed in West Virginia federal court alleges that Boston Scientific participated in an international conspiracy to sell defective vaginal surgical mesh made from counterfeit materials smuggled from China. The suit contains charges under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have
Drugs
Senator Tammy Baldwin (D-WI) has introduced a bill that would direct FDA to establish a public-private Standards Coordinating Body (SCB) for regenerative medicine. The Advancing Standards in Regenerative Medicine Act would also direct the agency to participate in developing such standards and to issue guidance on how these
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. It provides recommendations on submitting chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release
FDA Policy/General
BioLineRx Ltd. will collaborate with Merck to support a Phase 2 study of its BL-8040 in combination with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic pancreatic cancer. According to the companies, the multi-center study is designed to evaluate the safety and efficacy
FDA Policy/General
BIOLOGICS Guidance on Reducing Creutzfeldt-Jakob Disease Federal Register Notice: FDA is making available a guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry. It provides blood collecting establishments and
FDA Policy/General
DEVICES FDA has cleared a Conavi Medical 510(k) for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. The company describes it as the first catheter-based ultrasound system
FDA Policy/General
Federal Register Notice: CDER is sponsoring a public workshop 3/31 entitled “Navigating CDER: What You Should Know for Effective Engagement.” It aims to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. The workshop will be held from 8:30 a.
FDA Policy/General
Federal Register Notice: FDA will hold a public conference 3/23-24 entitled “How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?” This conference will be co-sponsored with the Critical Path Institute and will discuss, debate, and share views among