FDA Policy/General
Federal Register notice: FDA is withdrawing its guidance entitled “Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised).” The document was issued 6/2020 and it now is being withdrawn because the conditions that created the need
Drugs
Drug companies that receive complete response letters on their submissions cannot circumvent the agency’s hearing process to petition courts for redress. So says the Washington, DC Court of Appeals in a 6/3 decision that rejected a Nostrum Pharmaceuticals request for the court to hear arguments on the company’
Biologics
An FDA advisory committee briefing document says that Novavax’s Covid-19 vaccine’s two-dose primary series demonstrated significant efficacy, but it also showed similar risk signals seen with other Covid vaccines, such as myocarditis/pericarditis. The agency’s Vaccines and Related Biological Products Advisory Committee is being convened
Devices
FDA has released a final guidance entitled “Electromagnetic Compatibility (EMC)of Medical Devices” that offers the agency’s current thinking on recommended information that should be provided in a premarket submission to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions. The document says
FDA Policy/General
Federal Register notice: FDA is classifying the non-implanted electrical stimulation device for management of premature ejaculation into Class 2 (special controls). The action was based on a Virility Medical request for de novo classification of its vPatch. The agency has identified it as a device intended to be used
Drugs
India-based Lupin Pharmaceuticals has hired recently retired FDA New Jersey District director Diana Amador-Toro as the company’s senior vice president of global compliance. Based in Somerset, NJ, Amador-Toro presumably will be charged with helping to correct ongoing violations at Lupin’s New Jersey manufacturing facility. The
FDA Policy/General
The U.S. Government Accountability Office (GAO) has written HHS about the need for FDA to make it a high priority to act on inspection-related recommendations that are still open from previous GAO reports. One recommendation from a 1/28/2021 report (GAO-21-265) called for FDA inspection
Devices
U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) have introduced their bipartisan Strengthening Cybersecurity for Medical Devices Act that would mandate FDA to review and update medical device cybersecurity guidelines and suggestions to ensure devices are protected from possible hacking and cyberattacks. Text of the legislation
Drugs
FDA has extended the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. The new user fee review action target date is 9/29. The agency review extension will allow more time to review
Devices
FDA approved 5/25 the Apyx Renuvion dermal handpiece to be used with the company’s medical helium plasma generator for treating moderate to severe wrinkles and rhytides. A 6/2 updated agency safety communication says the new handpiece is limited to patients with Fitzpatrick skin types I, II, or
Drugs
FDA has released the FDA-483 issued following a multi-day inspection between 11/10/21 and 1/8/22 at CFP Acquisitions, a Tulsa, OK, producer of sterile drug products. The inspection observations were: * releasing drug product in which the strength differs from that it purports or is represented
Devices
A 4/10 HHS Office of Inspector General (OIG) advisory opinion says a specific physician-owned distributor of a medical device is structured in such a way that it will not face anti-kickback sanctions. Writing in a Washington Legal Foundation Legal Pulse, three Goodwin Procter attorneys say the OIG
Biologics
Gamida Cell has completed a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant. The BLA is based on data from a Phase 3 study showing that omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased
Drugs
Centessa Pharmaceuticals has decided to discontinue developing lixivaptan for autosomal dominant polycystic kidney disease (ADPKD). The company says its “strategic decision” to stop the Phase 3 ACTION study and the open-label ALERT study was based on a “thorough reassessment of the commercial potential of lixivaptan as a potential best-
Devices
FDA says a cybersecurity vulnerability is affecting software in several Illumina next-generation sequencing instruments. An agency statement says the Illumina devices may be specified for either clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions, or for research use only. The notice says
Biologics
FDA has issued Aeglea BioTherapeutics a refusal-to-file letter for its BLA for pegzilarginase, indicated for treating arginase 1 deficiency (ARG1-D). The letter requested additional data to support effectiveness, “such as evidence showing that plasma arginine and metabolite reduction predicts clinical benefit in patients with ARG1-D or
Drugs
FDA has accepted for review an sNDA submitted by Pfizer and Myovant Sciences for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). A Pfizer statement says the sNDA proposes updates to the Myfembree labeling based on safety and efficacy data from the Phase 3 LIBERTY
Devices
Atrium Medical has recalled its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from the delivery system when it is being removed from a patient. “This issue seems to occur most often when the stent system is used outside of the indications
Drugs
Three doctors have filed suit in a Texas federal court protesting FDA’s attempts to block the use of ivermectin to treat Covid-19. According to The Texan, the complaint says the agency has approved ivermectin for human use since 1996 for several diseases. But after the Covid-19 pandemic
Drugs
Sens. Maggie Hassan (D-NH) and Rand Paul (R-KY) have introduced legislation (S. 4338) they say will streamline the process for approving generic drugs. A statement says companion legislation was introduced in the House by Rep. Annie Kuster (D-NH) earlier this year. Hassan says the bill would require
Drugs
FDA has granted Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Kymriah was the first CAR-T cell therapy to receive regulatory approval 8/2017, for treating patients up to 25 years of age
FDA Policy/General
Federal Register notice: FDA is classifying coronary artery disease risk indicators using acoustic heart signals into Class 2 (special controls). The action is based on an Acarix’s request for de novo classification of its CADScor System. The agency has identified it as a device that records heart sounds including