Devices
FDA has cleared an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platform’s expanded use for endourological procedures. The clearance makes Monarch the first multispecialty, flexible robotic device for use in both bronchoscopy and urology, Auris says, adding that it is designed to enable urologists to reach
FDA Policy/General
Federal Register notice: FDA is withdrawing the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia. The company requested the withdrawal due to agency concerns that a postmarketing trial required to verify clinical
Drugs
FDA has issued a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and for toripalimab monotherapy in the second-line or later
Drugs
FDA has released a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide. The document provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to CDER/CBER. Updates to the guide since its 10/2019 release in draft
Devices
CDRH is rolling out organizational changes that include new offices established within the Office of Product Evaluation and Quality. For example, the Office of In Vitro Diagnostics and Radiological Health is being split into two new offices — the Office of Health Technology 7 within the Office of In Vitro Diagnostics,
Drugs
FDA has placed a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with Type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. The agency made a determination that there
Devices
After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel has announced he will be leaving the agency early this month to explore an undisclosed new chapter in his professional life. In an announcement on his Linkedin page, Patel said: “It truly has been an
FDA Policy/General
Guide on Bioavailability Studies for Drug Submissions 04/29/2022 Federal Register notice: FDA is making available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations. The document provides recommendations to sponsors planning to include bioavailability information in INDs, NDAs and supplemental NDAs. To view the
FDA Policy/General
DEVICES FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,
FDA Policy/General
Helsinn and MEI Pharma have entered into a licensing, development and commercialization agreement for pracinostat, a Phase 3-ready drug candidate for treating acute myeloid leukemia and other potential indications. Under the agreement, Helsinn will get exclusive worldwide rights, including manufacturing and commercialization rights, and will be responsible for funding
Drugs
FDA has sent an email to Praxis Precision Medicines placing a clinical hold on PRAX-222, an antisense oligonucleotide for treating patients with SCN2A gain-of-function epilepsy. The company had been planning to begin a seamless study of PRAX-222 this quarter for treating SCN2A developmental and epileptic encephalopathy.
Devices
FDA is warning healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may instead have a welding defect in the internal pump causing the pump to malfunction. According to a just-released Medtronic Urgent Medical
Drugs
CDER’s Office of Compliance (OC) says its priorities for 2022 include supporting FDA’s Covid-19 response (supporting new therapy development and protecting the public from harmful and illegal products), reducing harm caused by opioid crisis, and improving the agency’s oversight of drug compounding operations. In a just-
Drugs
FDA has released a draft guidance entitled Crohn’s Disease: Developing Drugs for Treatment. The document addresses the agency’s current recommendations on clinical trials for Crohn’s Disease (CD) drugs being developed, such as trial population, trial design, efficacy considerations, and safety assessments. FDA notes that the guidance does
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Gilead Sciences under the agency’s material threat medical countermeasure program. FDA determined that recently approved Veklury (remdesivir) meets the criteria for such a voucher. To view the notice, click here.
Drugs
FDA has lifted a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical development for preventing recurrent C. difficile infection (CDI). “The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-
Biologics
June is shaping up to be one of the busiest months in recent FDA history for agency vaccine reviews and associated meetings by its Vaccines and Related Biological Products Advisory Committee. The agency has set tentative advisory committee dates in anticipation of receiving complete emergency use authorization (EUA) submissions. The
Drugs
FDA has released a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment. The document addresses FDA’s current thinking on the necessary attributes of clinical trials for such drugs, including trial population, trial design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations of ulcerative colitis
Devices
FDA has updated its “Digital Health Policies and Public Health Solutions for Covid-19” Web page. An agency statement says the update: * provides examples of software functions identified in guidances issued during the Covid-19 public health emergency; * reflects policies and legislation currently in effect, including the software provisions of
FDA Policy/General
Federal Register notice: FDA has determined that Abraxis Pharmaceutical’s cupric sulfate injection was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The product is indicated to
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 1/22/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Providing Submissions in Electronic Format — Postmarketing Safety Reports. The document provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs, and other postmarketing safety reports) for certain human drugs, biological