FDA Policy/General
Federal Register notice: FDA has announced a 3/21 Neurological Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on clinical information related to a de novo request for the NeuroAD Therapy System that was submitted by Neuronix. The device is
FDA Policy/General
Federal Register notice: FDA has announced a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss an AllerQuest NDA for Pre-Pen Plus, a skin-test kit that combines the approved product Pre–Pen (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” The document is intended to assist NDA/ANDA holders with their submission of required marketing status notifications. To view the notice, click
Drugs
Writing in a Washington Legal Foundation Legal Opinion Letter, Seton Hall University School of Law professor Howard Dorfman says that while the Centers for Medicare and Medicaid Services (CMS) may want to empower patients and lower prescription drug costs, its proposed rule to require drug companies to include a drug’
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Guoguang Touring Commodity Co. Zhejiang, China (12/14): FDA inspected the firm 4/2018 and cited it for significant GMP violations for finished pharmaceuticals. For example, the firm
FDA Policy/General
FDA has yet to propose regulations to align its regulations on protection of human subjects with the revised Federal Policy for the Protection of Human Subjects (known as the Common Rule). Three Morgan Lewis attorneys write in an online blog post that the agency is aware of new inconsistencies between
FDA Policy/General
DEVICES FDA has approved a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the sensor on the upper arm. The company says this is the only sensor FDA approved to control automated insulin delivery via a hybrid
FDA Policy/General
Officials of 50 healthcare groups representing patients, caregivers, healthcare providers, and researchers wrote 1/22 to President Trump and the leaders of both parties in the House and Senate to express “alarm at the continued government shutdown, particularly its impact on FDA.” The letter says the groups “are greatly concerned
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it spent a record $27.5 million on lobbying in 2018. Bloomberg News reports that the “surge in spending … came as the industry failed to win a last-minute legislative fix that would have reduced its share of outlays in a popular
FDA Policy/General
A CBS Morning News 1/22 report on the government shutdown included a profile on an Illinois-based FDA food safety investigator Larry Stringer, who describes the hardships his family is undergoing due to missed paychecks. The investigator says he and his wife are dipping into savings to continue to
FDA Policy/General
BIOLOGICS Seqirus has received FDA approval of Afluria Quadrivalent (Influenza Vaccine) for use in persons 18 years of age and older. The company says it is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency is curbing “discretionary activities” and looking to order furloughs in areas where the workload has dropped during the partial government shutdown to preserve resources for drug reviews. In a 1/17 interview with the Washington Post, he said “What we are trying to
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/21) in observance of Martin Luther King day. Nightly emails will resume 1/22.
FDA Policy/General
FDA has ordered about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections across food and medical product programs. In a series of tweets, commissioner Scott Gottlieb said about 100 staff are focused on inspections of high-risk medical device
FDA Policy/General
Concerned that the partial government shutdown affecting FDA will have lingering effects over the course of the year impacting medical product reviews/approvals and its oversight of the food supply, a group of 34 Senate Democrats have sent a letter to commissioner Scott Gottlieb requesting information on the potential damage
FDA Policy/General
DEVICES FDA has cleared a Delta Med 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge
FDA Policy/General
As thousands of FDA employees missed their normal paychecks 1/11, FDA commissioner Scott Gottlieb posted a special note of gratitude for their dedication to their public health mission. “I deeply regret these hardships,” he said on his Twitter feed. “And I admire very much their continued dedication to our
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that while its goal is to provide comments on draft promotional materials within 45 days of the voluntary submission of the materials by sponsors, some recent draft materials “have raised complex issues that required additional review, resulting in review times that
Drugs
Former Insys Therapeutics CEO Michael Babich has pleaded guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Late last year, formr company vice president Alec Burlakoff also pleaded guilty in the scheme
FDA Policy/General
Researchers at the Center for Medicine in the Media and the Dartmouth Institute for Health Policy say that medical marketing increased substantially from 1997 through 2016, especially direct-to-consumer (DTC) ads for prescription drugs and health services. Writing in a Journal of the American Medical Association special communication, the
FDA Policy/General
Furloughed FDA employees told CNN 1/8 they feared the partial government shutdown at the agency could cost lives. The network quoted FDA Detroit laboratory chemist Geneve Parks as saying "With the shutdown, surveillance is not effective. They are doing the bare minimum to get by." She said
FDA Policy/General
The U.S. House of Representatives is planning to vote this week to fund FDA under an Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill as a standalone measure. “Because of the Trump Shutdown, some of the most important activities funded in the Agriculture bill have