Devices
FDA has granted a de novo marketing authorization for Cue Health’s Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing authorization outside of the agency’s emergency use authorities. The molecular nucleic acid amplification test (NAAT) is intended to detect genetic material from
Drugs
Norwich Pharmaceuticals is suing FDA in the DC federal court over its “arbitrary, capricious, and unlawful refusal to grant Norwich’s amended ANDA final approval” for the 550 mg strength of rifaximin (Salix’ Xifaxan) to treat irritable bowel syndrome with diarrhea. The suit says that in an 8/2022 decision,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally agrees with the recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in manufacturing under section 506C of the Federal Food, Drug, and Cosmetic Act. In a comment letter, PhRMA says the additional clarity provided
Drugs
Staff in CDER and the Oncology Center of Excellence say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhibitor (IO/TKI) combination therapy benefit was greater in the intermediate/poor-risk group than the favorable risk group. Writing in European Urology, the researchers say they pooled four frontline
Drugs
FDA has placed an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP violations documented in a 5/2022 inspection of the facility. According to an FDA Letter referencing the import alert, 14 medically necessary products made by the company are being
FDA Policy/General
FDA is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health emergency is winding down. Speaking at an Alliance for a Stronger FDA virtual staffing update 6/5, FDA chief of staff Julie Tierney said that so far in fiscal year 2023 there
Devices
Abiomed has recalled (Class 1) its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the device’s purge sidearm. “If a purge leak occurs the system will experience low purge pressures, prompting alarms and requiring evaluation,” a recall notice says. “If the leak issue
Devices
FDA has sent a “Dear Doctor” letter about “supply constraints” involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S. The devices are mainly used in elective limb surgeries and in emergency and trauma settings. During the supply issue, the agency is recommending that health care providers use
Drugs
FDA has removed a partial clinical hold against Foghorn Therapeutics’ Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Foghorn says it will begin a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed or refractory
Devices
Draeger Medical has recalled (Class 1) its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. A recall notice says that FDA has determined that the faulty parts are the
Drugs
FDA has placed an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations documented in a 12/2022 inspection of the facility. According to an FDA letter referencing the import alert, 25 medically necessary products made by the company are being
Drugs
FDA has extended by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors. The previous user fee review action date was 8/27. FDA told the SpringWorks that it required more time to review the company’s analyses of submitted data that
Drugs
FDA has posted a final guidance entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” The document is intended to assist ANDA sponsors with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, and amendments and supplements to ANDAs. The cover letter
FDA Policy/General
FDA has released a final guidance entitled “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” Focused on nonclinical safety evaluations by sponsors, it defines immunotoxicity as “any adverse unintended immunosuppression or stimulation, which can be the result of off-target effects or exaggerated pharmacology of pharmaceuticals that are intended to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Drug-Drug Interaction (DDI) Assessment for Therapeutic Proteins.” The document is intended to help stakeholders determine the need for DDI studies for a therapeutic protein using a systematic, risk-based approach. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.” The document includes recommendations for drug development programs for drugs intended to treat patients with the syndrome. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Migraine: Developing Drugs for Preventive Treatment.” The document focuses on specific drug development and trial design issues that are unique to drugs being developed for preventing migraines. To view the notice, click here.
Drugs
FDA has lifted a two-month-long partial clinical hold on a Molecular Templates (MTEM) Phase 1 multiple myeloma study of MT-0169 that was based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg, which prompted a dose reduction from 50 mcg/kg
Drugs
Senator Dick Durbin (D-IL) is urging FDA to take immediate action to improve supply shortages of critical cancer drugs. In a 6/1 letter to FDA commissioner Robert Califf, Durbin cited shortages with two chemotherapy drugs — carboplatin and cisplatin — that are used in treating hundreds of thousands of cancer
Biologics
FDA has granted Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for treating patients with refractory lupus nephritis. KYV-101 is designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients, the company says, adding that a
Drugs
FDA has posted a final guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. “Due to the evolving knowledge of novel
Devices
FDA has posted a final guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document includes minor procedural updates and clarifications related to scheduling pre-submission meetings for investigational medical devices. Under the Medical Device User Fee Amendments of 2022, new performance goals