Drugs
Torrent Pharmaceuticals has expanded its recall from 10 lots of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazide tablets due to the detection a suspected carcinogenic impurity, N-nitrosodiethylamine (NDEA) in an active pharmaceutical ingredient manufactured by Hetero Labs Limited. NDEA occurs naturally in certain foods,
Devices
FDA has cleared a Rebound Therapeutics 510(k) for the Aurora Surgiscope System, which the company describes as the world’s first single-use disposable neurosurgical endoscope for minimally invasive access, visualization and illumination of target neuro anatomy. The device comprises two components — a sterile, single use, neurological endoscope called
Drugs
FDA has accepted for review two Merck supplemental NDAs for Pifeltro (doravirine, 100 mg) and Delstrigo (doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg). The applications seek approval for Pifeltro (in combination with other antiretroviral medicines) and Delstrigo for use in people living with HIV-1
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
Devices
FDA has published a guidance, Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection, with recommendations to facilitate industry development and validation of assays for assessing the immunogenicity of therapeutic protein products during clinical trials. Specifically, the document includes guidance on the development and
Drugs
FDA has denied an 8/2/17 American Dental Association petition asking the agency to open the rulemaking process to review and update five over-the-counter oral health drug product monographs. The petition said many of the monographs had not kept pace with the latest science-based testing standards,
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
Devices
The Duke-Margolis Center for Health Policy says artificial intelligence (AI) has been introduced into many areas of medicine, including clinical decision support (CDS) software. It has issued a report examining the benefits and challenges when AI has been incorporated into CDS software, particularly software that supports improved clinical diagnosis,
Devices
FDA has cleared an Imperative Care 510(k) for its line of neurovascular access catheters, which are intended to deliver interventional treatments during neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions. The devices are designed to “enable smooth, consistent navigation deep into blood vessels of the brain,
Drugs
The Senate Finance Committee has announced a 1/29 hearing on “Drug Pricing in America: A Prescription for Change, Part I.” The 10:15 a.m. hearing will be chaired by chairman Chuck Grassley (R-IA). It is the first in a series of hearings “scrutinizing prescription drug pricing and
Drugs
FDA has placed on clinical hold a Translate Bio IND submission for MRT5201 for treating ornithine transcarbamylase (OTC) deficiency, due to additional clinical and nonclinical questions. The company submitted the IND in December to support the initiation of a Phase 1/2 clinical trial in patients with OTC deficiency. It
Drugs
FDA has cleared a United Imaging 510(k) for the uExplorer total-body scanner, which is described as the world’s first medical imaging scanner that can capture a 3D picture of the whole human body at one bed position. The device is a combined positron emission tomography and x-
Drugs
Janssen Biotech has submitted the first part of a supplemental BLA for a label expansion to include the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant. The
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 8 to 8 on whether to recommend approval for Lexicon Pharmaceuticals Inc and Sanofi’s sotagliflozin for treating Type 1 diabetes as an add-on to insulin therapy. Panel members were concerned about a safety signal that FDA raised in
Drugs
FDA has issued a guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway, to assist applicants in developing the Indications and Usage section of labeling for human prescription drug and biological products approved under the accelerated approval regulatory pathway. More specifically, the document
Drugs
FDA has released a draft International Council for Harmonization guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines, recommending international standards for, and promoting harmonization of, the nonclinical safety studies recommended to support development of pediatric medicines. The document recommends an approach for the nonclinical safety evaluation
Devices
FDA has issued a guidance, Safety and Performance Based Pathway, with the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document’s intent is to describe an optional pathway (the Safety and Performance Based Pathway)
Biologics
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says FDA has a number of enforcement options it can turn to after its enforcement discretion for stem cell facilities and certain other HCT/P manufacturers ends 11/2020. Writing in his firm’s FDA Law Blog, Schwartz says FDA indicated in a
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
Devices
FDA has cleared a 23andMe 510(k) for the MUTYH-Associated Polyposis report, a genetic health risk report on a hereditary colorectal cancer syndrome. The report follows a 3/18 clearance for the company’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report on the same ancestry and health service
Drugs
FDA has granted Albireo Pharma an orphan drug designation for A4250, an ileal bile acid transporter inhibitor for treating biliary atresia, a rare and life-threatening liver disease with no approved pharmacologic treatment option. The company describes A4250 as a first-in-class product candidate being developed to treat rare
Drugs
FDA oncology researchers say that patient-reported outcome (PRO) assessments can contribute important information about the patient experience during treatment with anticancer products and use of such assessments is likely to increase. Writing in JAMA Oncology, the researchers say randomized oncology trials are increasingly open-label, and the accelerated approval