Devices
FDA has cleared a Qardio 510(k) for its QardioCore ambulatory electrocardiogram (ECG) device for holter monitoring applications, including its use with QardioMD, a cloud-based remote patient monitoring application. The device is intended to capture continuous ECG rhythms. It also displays full-disclosure ECG reports and may be used
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer video of an interview with Khloé Kardashian, a paid Biohave Pharmaceuticals spokesperson, which aired 7/15/20 on The View and also was the subject of an FDA Bad Ad Program complaint, contains false or misleading claims
FDA Policy/General
Six former FDA commissioners are urging President Biden to prioritize the nomination and confirmation of an FDA commissioner. In a 3/9 letter, the group expressed concern about the Trump Administration’s interference with the agency’s independence and lack of support to carry out essential science-based regulatory activities
Drugs
FDA has accepted for review an Idorsia NDA for its investigational dual orexin receptor antagonist, daridorexant, for treating adult patients with insomnia. The submission includes data from the company’s Phase 3 registration program, which the company says showed that daridorexant demonstrated statistically significant and clinically meaningful improvements in sleep
Devices
Former FDA lawyer Laurie Clarke has joined TSG Consulting as vice president and principal of its medical device regulatory practice. The company says Clarke “will lead TSG Consulting’s established medical device regulatory team, as well as collaborate with medical device advisory and product development teams at sister company Sargentia,
Biologics
A Pfizer facility in McPherson, KS, that is slated to start producing the company’s Covid-19 vaccine has a long history of mold and other contamination issues, according to inspection reports obtained by Kaiser Health News (KHN). The news service says “FDA investigators have repeatedly noted in reports that
Drugs
FDA has granted Vertex Pharmaceuticals a fast track designation for VX-880 for treating patients who have Type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness. The company says the first clinical trial sites at the University of Miami Health System, the University of Pennsylvania and Massachusetts General Hospital
Drugs
Bryant Ranch Prepack has recalled four lots of spironolactone tablets after determining they have been mislabeled and display the incorrect strength. “Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets,” a recall notice says.
Drugs
Lannett says it is incorporating feedback recently received from FDA into the design of a pivotal trial, including the type and size of the trial and primary and secondary endpoints, for biosimilar insulin glargine that Lannett is developing with partners within the HEC Group. The company says it sought and
Drugs
The Pharmaceutical Distribution Security Alliance (PDSA) says it joins with the Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage in asking FDA not to authorize Florida’s proposed drug importation program. In a comment to the citizen petition submitted by
Devices
Attorney Jim Shehan (Lowenstein Sandler) says FDA managed to largely fulfill its core responsibilities of ensuring compliance and helping bring new products to market in 2020 despite having to cope with the Covid-19 pandemic. Writing in a Med Device Online guest column, Shehan says that based on the 2020
Devices
FDA has cleared an Akesis 510(k) for the Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system (SRS) with continuous 360-degree rotational technology and real-time, in-line imaging. The company says the imaging system is on a rigid ring-gantry at the treatment plane, eliminating the need
Drugs
A recent inspection at Dr. Reddy’s Laboratories’ active pharmaceutical ingredient (API) manufacturing plant in Middleburg, NY cited three observations on a Form FDA-483. The company says it will address the undisclosed findings within the agency’s stipulated timeline. “Currently, we do not have any sales from this plant,
Drugs
Nine FDAers led by FDA Office of Women’s Health director of scientific programs Marjorie Jenkins say the agency “has made measurable progress incorporating consideration of sex and gender differences into drug trial development and FDA consideration of these data, supporting inclusion of women in clinical trials, providing a comprehensive
Biologics
Govs. Jared Polis (CO) and Kate Brown (OR) are asking FDA acting commissioner Janet Woodcock to permit the pooling of Covid-19 vaccines by granting a short-term emergency waiver for experienced practitioners. In their 3/8 letter, Polis and Brown say vaccine pooling is a common practice routinely used
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Evelyn Lopez-Brignoni, Palmetto, FL (3/2) FDA inspected the physician’s medical practice in June 2020 and cited objectionable conditions in its conduct of two clinical trials. For
Drugs
Writing in a Science blog, Derek Lowe says a report on FDA drug approvals over the last 10 years is “a pretty encouraging read.” The analysis of drug approvals was prepared by two Jnana Therapeutics employees and published in the Journal of Medicinal Chemistry. The authors found that 378 novel
Drugs
A 6/8-6/23/20 FDA Bioresearch Monitoring Program inspection at a Palmetto, FL, medical practice operated by Evelyn Lopez-Brignoni found objectionable conditions in the practice’s conduct of two clinical trials. A 3/2 Warning Letter says the practice “did not adhere to the applicable statutory requirements
FDA Policy/General
CDER and CVM compliance officials say their review of a Web site and social media pages maintained by Cannafyl, Scottsdale, AZ, indicated that it takes orders for various human and animal products containing cannabidiol. A 3/1 Warning Letter says the products being sold for humans are intended to mitigate,
Drugs
FDA has told Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and delusions associated with dementia-related psychosis, has found deficiencies that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency stated that its communication about the
Devices
FDA has issued a table to be used with its 11/2020 immediately-in-effect guidance Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the Federal Food, Drug, and Cosmetic Act During the Covid-19 Public Health Emergency. The table contains the agency’s recommendations
Drugs
Sandoz has filed suit in DC federal court asking it to overturn FDA’s award of new chemical entity exclusivity to Sanofi Genzyme’s multiple sclerosis drug Aubagio (teriflunomide). The suit also asks the court to order FDA to accept Sandoz’ ANDA for a generic form of Aubagio as of