FDA Policy/General
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/25 from 8 a.m. to 5 p.m. at FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD. The committee will discuss the safety
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/7, from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/8 from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
FDA Policy/General
Bipartisan Senate HELP Committee leaders have introduced legislation to help FDA and the National Institutes of Health (NIH) to “attract top talent during this exciting time in science.” The FDA and NIH Workforce Authorities Modernization Act also would authorize the two agencies to streamline coordination and cut red tape. A
Drugs
The DC federal court has rejected part of a Ferring Pharmaceuticals challenge to FDA over an exclusivity period for its Prepopik fixed-dose combination drug. It also asked both sides for further briefing on another aspect of the challenge. Ferring sought a five-year exclusivity for the drug because one
Drugs
Sens. Mark Kirk (R-IL), Joe Manchin (D-WV), and Susan Collins (R-ME) have introduced legislation that includes a conditional approval pathway for new regenerative medicine treatments that have the potential to restore or establish normal function in damaged human cells, tissues, and organs. Companion legislation was introduced in
Drugs
Camargo consultant William Stoltman says that a recent CDER/CBER guidance on the extent of safety data collection needed in late-stage premarket and post-approval clinical investigations may provide a significant reduction in safety data collection for NDA sponsors, and especially for those using the 505(b)(2) regulatory
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that FDA should provide transparency on how it plans to process, interpret, and use quality metrics data to be reported by industry. A PhRMA Catalyst blog post on the quality metrics proposal says that agency sharing of information “is critical so that
Devices
The Association for Molecular Pathology (AMP) says it is “concerned and disappointed” over FDA enforcement action against doctors at two Texas hospitals for their laboratory-developed test for the Zika virus. “Given the ongoing outbreak of the infection in the Houston area, these types of tests are critical for patient
FDA Policy/General
In her first interview since leaving her position as FDA commissioner, Margaret Hamburg says that one of the challenging things in her years on the job was that “we didn’t have a lot of advocates on the Hill. Often, even the White House really was a little bit suspect
Devices
Department of Justice (DoJ) prosecutors are behaving like Mafia enforcers in their tactics with medical device companies they accuse of “corporate wrongdoing,” according to Minneapolis-based Vascular Solutions CEO Howard Root, who last month was acquitted by a jury of all DoJ felony charges brought against him in an off-
FDA Policy/General
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/24, from 8 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 the safety
FDA Policy/General
Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 5/11 from 1 p.m. to 4:30 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will participate
Drugs
Lupin has acknowledged that FDA completed an inspection last week at its Goa, India manufacturing plant. The agency issued a nine-item Form-483 related to “inadequacy and adherence to SOPs,” the company says, adding that it is preparing a response. The Goa facility manufactures a range of finished products
Drugs
Lilly is changing the primary endpoint of its EXPEDITION3 clinical trial of its solanezumab in people with mild Alzheimer’s dementia. The company says that the original study design included co-primary endpoints of cognition and function. With emerging scientific evidence supporting the idea that cognitive decline precedes and predicts
FDA Policy/General
A coalition representing research and policy organizations, producers, purchasers, and infectious disease doctors and scientists has written to the House and Senate Appropriations Committees calling for funding in the FY 2017 budget to support implementation of the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB). The 3/16 letter
Drugs
FDA has granted Novimmune a breakthrough therapy designation for NI-0501 and its use in treating patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory disease, or with recurrent or progressive disease during conventional therapy. The therapy is a fully human, anti-interferon-gamma monoclonal antibody that received an orphan drug
Devices
FDA has cleared an InfoBionic 510(k) for MoMe Kardia, a wireless, remote monitoring system designed to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for such monitoring. The three-in-one device transitions between Holter, Event and Mobile Cardiac Telemetry modes remotely, which is intended
Devices
FDA’s Circulatory System Devices Panel has voted 9-0 to recommend approval of an Abbott PMA for the first fully absorbable drug eluting stent. Agency reviewers had determined that clinical data submitted showed that the device was not inferior to a traditional stent, according to a briefing document released
Drugs
Four Faegre Baker Daniels attorneys say that two recent decisions involving Alcon and Lilly demonstrate that it may be difficult for branded drug companies to prevent a litigation stay in view of pending inter partes review (IPR) proceedings. (Inter partes review is a procedure to challenge a patent’s validity
Drugs
A 3/14 FDA draft guidance explains how the agency will implement Biologics Price Competition and Innovation Act (BPCIA) provisions for moving protein products currently approved under the drug statute to the biologics system. The BPCIA requires that as of 3/23/20, all NDAs and ANDAs for protein products
Devices
A 10/26-11/10/15 FDA inspection at Sure Tek Medical, Greenville, SC, found Quality System Regulation violations in the firm’s manufacturing of medical devices such as orthopedic and laparoscopic instruments. A 3/3 Warning Letter from the agency’s Atlanta District Office says that procedures for monitoring