Biologics
FDA has placed a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died. MELANI-01 is a Phase 1 dose escalation clinical study evaluating a gene-edited T-cell product candidate (UCARTCS1A) for treating patients with relapsed or refractory multiple myeloma, according to
FDA Policy/General
A House appropriations subcommittee has approved by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021. The vote advances FDA’s budget totaling $3.212 billion in discretionary funding. Total funding for the agency, which includes user fees, is $5.99 billion. “Within
Drugs
FDA has published a list of REMS updates for five drug products. The list shows changes for Akcea’s Tegsedi (inotersen), Celgene’s Pomalyst (pomalidomide), Takeda’s Natpara (parathyroid hormone), Indivior’s Sublocade (buprenorphine extended-release), and Zogenix’ Fintepla (fenfluramine).
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Greiner Bio-One, Monroe, NC (4/16): FDA inspected the firm 12/2019 and cited GMP violations for its medical device (Vacuette brand blood collection tubes). For example, Greiner
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class 1 and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.” The document describes FDA’s intention with respect to
Drugs
FDA has approved Genentech’s Phesgo (pertuzumab, trastuzumab, and hyaluronidase ZZXF) for injection under the skin to treat adult patients with metastatic HER2-positive breast cancer, and for treating adult patients with early HER2-positive breast cancer. An agency announcement says patients should be selected based on an FDA-approved
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of Anti-Infective Drug Products for the Pediatric Population.” The document addresses initiation of pediatric clinical studies, enrollment strategies, efficacy extrapolation, and other considerations to help facilitate pediatric anti-infective drug product development. To view the notice, click
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for intravenous injection for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The agency says it is the first immunotherapy approved for this patient population as a first-line treatment that is administered
Drugs
FDA has published a draft guidance, Development of Anti-Infective Drug Products for the Pediatric Population, with general recommendations on developing anti-infective drug products for the pediatric population. The document does not address the full scope of considerations for pediatric anti-infective drug development. Additional information is available through
Biologics
FDA has issued an immediately-in-effect guidance, Development and Licensure of Vaccines to Prevent Covid-19, to assist sponsors in developing coronavirus vaccines and to reassure the public that the agency will use high standards in considering any vaccine for approval. The document will remain in effect for the
Devices
FDA has warned consumers and healthcare professionals about hand sanitizer products containing methanol. An agency notice says that methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. “The agency has seen an
Drugs
FDA has rejected Intercept Pharmaceuticals’ obeticholic acid for treating NASH (nonalcoholic steatohepatitis). Endpoint News reports that FDA postponed two advisory committee meetings that were to consider the company’s NDA and then rejected the drug because agency staff were uncertain if the Phase 3 trial surrogate endpoint (reduction in liver
Drugs
FDA has approved ViiV Healthcare’s Rukobia (fostemsavir), described as a “new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance, or safety considerations.” An agency statement says Rukobia’
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in children under 12 years of age, and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with
Drugs
At the request of FDA, the National Academies of Science, Engineering, and Medicine (NASEM) has conducted an independent assessment and evaluation of the available scientific evidence on the safety and effectiveness of compounded bioidentical hormone therapy (cBHT) products. NASEM concluded that due to a lack of high-quality clinical evidence
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees” (OMB Control Numbers 0910-0540). The collection supports information associated with the Animal Drug User Fee cover sheet. To view the notice, click here.
Devices
The American College of Radiology and the Radiological Society of North America say it is unlikely that FDA could provide reasonable assurance of the safety and effectiveness of autonomous artificial intelligence (AI) in radiology patient care without more rigorous testing, surveillance, and other oversight mechanisms throughout the total product life
Biologics
Three academic researchers say the best response to concerns raised about the Trump administration’s Operation Warp Speed approach to developing a Covid-19 vaccine “is a transparent and rigorous approach to vaccine development and regulation, including for licensure or any pre-licensure use permitted by FDA. For this effort
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Auro Pharmacies, La Habra, CA (6/3): FDA inspected the firm 7/2018 and cited serious deficiencies in its practices for producing sterile drug products. For example, FDA investigators
Drugs
An FDA safety alert is warning about an increased risk of a false positive result with Becton Dickinson’s BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found 3% of results were false positive for Covid-19, the alert says. The agency
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile” (OMB Control Number 0910-0614). The collection addresses (XXX SUBSTITUTE XXX) when it may be appropriate for certain medical products held in the
Drugs
The Justice Department says Novartis will pay $678 million to the federal government and several states to settle a whistleblower’s civil fraud suit alleging that the company violated the False Claims Act and anti-kickback laws by providing doctors cash payments, recreational outings, lavish meals, and expensive alcohol to