Drugs
FDA has approved Jazz Pharmaceuticals’ Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. An agency statement says
FDA Policy/General
7/2/2021 Topical and Transdermal Adhesion Assessments Guide Federal Register notice: FDA has made available a draft guidance entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. To view the notice, click here. Guide on CNS Cancer Drugs Federal Register notice: FDA has made
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Tuesday, July 6. The next overnight email news bulletin from this site will be issued that evening.
Drugs
FDA has posted a draft guidance on Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. The document provides recommendations to help sponsors comply with the expedited safety reporting requirements under an IND or as part of a bioavailability or bioequivalence study that is exempt
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Class II Special Controls for Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests.” The collection is intended to support a 2020 proposed order to reclassify certain HIV
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements — 21 CFR Part 203” (OMB Control Number 0910-0435). To view the notice, click here.
FDA Policy/General
The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 6/25 has approved by voice vote FDA’s s fiscal year 2022 budget bill. Under the measure, the agency would receive $3.471 billion in discretionary funding in the bill, an increase of $257
Devices
Avid Medical has recalled (Class 1) medical convenience kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with Aspergillus penicillioides. Contaminated kits could cause serious systemic infection, sepsis, illness, and death to a patient, a recall notice says. “If the fungus is introduced in
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings. The document provides recommendations on cancer drug trials regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment
Drugs
FDA has told AbbVie that it will not meet the user fee action dates for two supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The agency cited its ongoing review of Pfizer’s post-marketing study, ORAL
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings, with recommendations for including patients who have not received available therapy for their cancer in clinical trials of investigational drugs and biological products in a non-curative setting. The document says
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Covid– 19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. The document primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial effectiveness evidence and adequate
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Zolgensma (onasemnogene abeparvovec-xioi), indicated for treating pediatric patients with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene. The regulatory review period is 2,088 days, which includes
FDA Policy/General
Rep. Diana DeGette (D-CO) says she and Rep. Fred Upton (R-MI) have drafted wording to be included in a circulating Cures 2.0 bill that would, among other things, create an Advanced Research Projects Agency for Health (ARPA-H) that is sought by President Joe Biden to develop
Drugs
Members of the Oncologic Drugs Advisory Committee voted 13-4 on 6/24 to recommend that FDA defer regulatory action on Incyte’s retifanlimab, pending more research. The company is seeking an indication to treat patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed
Biologics
FDA has accepted for priority review a Genentech BLA for its Port Delivery System with ranibizumab (PDS) for treating wet, or neovascular, age-related macular degeneration (AMD). Wet AMD is a leading cause of blindness for people aged 60 and over and affects about 1.1 million people in the
FDA Policy/General
Federal Register notice: FDA has announced a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs. The workshop is intended to discuss the challenges and clinical trial design considerations for developing such therapeutic products. To view the notice, click here.
Drugs
FDA has granted breakthrough therapy designations for drugs from Lilly and Eisai/Biogen intended to treat Alzheimer’s disease. The designation was granted for Lilly’s donanemab, an investigational antibody therapy. The company says the designation is based on clinical evidence in the TRAILBLAZER-ALZ Phase 2 trial that studied
Drugs
A 7/22/19-8/14/19 FDA inspection at Roger Williams Medical Center Oncology Pharmacy Clinic, Providence, RI, found deficiencies in the clinic’s practices for producing compounded sterile drug products that put patients at risk. A just-released 3/18 Notice of Violation says the agency investigators found
Devices
FDA has approved an Oticon Medical PMA for the company’s Neuro System to treat individuals 18 years or older with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aids. The device is the first cochlear implant system to be approved in more
FDA Policy/General
Retired FDA psychiatry products director Thomas Laughren has joined Cybin as a clinical advisory board member. The biotechnology company is focused on progressing psychedelic therapeutics, and it says Laughren is familiar with the potential challenges, and he brings extensive psychiatric regulatory and development expertise to its advisory board. Laughren retired
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. The document is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing,