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
Devices
Brainlab has recalled its Cranial IGS System due to potential inaccuracies in displaying the position of surgical instruments relative to the patient anatomy, which could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death. The device shows the area of interest and an instrument’s position
Drugs
An FDA inspection has again cited Indian drug firm Wockhardt Ltd. for manufacturing violations. In 2013, a Warning Letter cited significant GMP violations, including data integrity concerns, for finished pharmaceuticals at the company’s manufacturing facilities in Chikalthana and Waluj. Two days after the letter was issued, the agency announced
Biologics
FDA has approved an expanded age indication for GlaxoSmithKline’s Hiberix [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)]. The vaccine is now indicated for immunizing children aged six weeks through four years against invasive disease caused by Haemophilus influenzae type b (Hib). Approvals was based on data showing immune responses
Drugs
FDA reviewers are raising concerns that data are not sufficient to allow approval of a Sarepta Therapeutics NDA for eteplirsen, indicated for treating Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In briefing materials released in advance of a 1/22 Peripheral and Central Nervous System Drugs Advisory Committee
Devices
FDA has cleared an Olympus 510(k) for the TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. The company intends to recall its original model currently being used in health care facilities and make the needed repair