Drugs
FDA has granted Mesoblast an orphan drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic left heart syndrome. The designation is based on data from a randomized controlled trial, which the company says demonstrated that a single intramyocardial administration of Revascor at the
Drugs
FDA is several weeks late in issuing a guidance on how and when drug and medical device companies must submit diversity action plans for clinical trial research, according to a Regulatory Affairs Professionals Society (RAPS) Regulatory Focus online post. The December 2022 Food and Drug Omnibus Reform Act requires manufacturers
Drugs
FDA has granted Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in recently diagnosed Stage 3 Type 1 diabetes patients with the genotype HLA DR3-DQ2. Antigen-specific therapy Diamyd is currently being evaluated in what the company calls the first-
Devices
FDA has cleared a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System. The device supports implantation of up to four different reflector configurations, according to the company. “When implanted within abnormal breast or other soft tissue, the reflectors are designed to pinpoint tumor location in multiple
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” The document addresses frequently asked questions related to FDA’s regulation on charging for investigational drugs used in clinical trials or an expanded access for treatment use request. To
FDA Policy/General
Federal Register notice: FDA is announcing that its Office of Digital Transformation has modified its organizational structure. The new structure was approved by HHS on 12/21/2023 and is intended to consolidate similar functions and resources across multiple areas and align them with federal and industry standards. To view
Drugs
Harvard Medical School assistant professor of medicine Peter Cohen says FDA is not doing all it could to keep harmful products sold as dietary supplements out of the hands of consumers. Interviewed 2/13 on the PBS News Hour, Cohen specifically referenced tianeptine, commonly known as “gas station heroin” and
Drugs
FDA has denied a Zydus Pharmaceuticals (USA) 9/13/2023 petition asking the agency to take specified actions about indomethacin suppositories, 50 mg. Zydus is one of the manufacturers of this generic product. The petition asked that FDA: * ensure that the currently marketed reference standard for the suppositories approved under
Drugs
FDA has released the form FDA-483 issued following a 1/22-2/2 inspection at Eugia Pharma Specialties Limited, a sterile drug manufacturer in Sangareddy, Telangana, India. The nine inspection observations in the 26-page form were: * failing to establish and follow procedures designed to prevent microbiological contamination of
Biologics
Citius Pharmaceuticals has resubmitted a BLA for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. The resubmission addresses issues raised in a 7/28/2023 complete response letter. “Citius believes it has
Drugs
FDA has approved an Eicos Sciences NDA for Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The drug’s efficacy was established in an open-label, controlled trial involving 47 adults with severe frostbite, according to an FDA release. Patients
Devices
Smiths Medical ASD is recalling (Class 1) its Medfusion model 4000 syringe pump due to issues associated with earlier software versions. According to a recall notice, the issues may affect the alarm system, the pump, the control screen, and other parts of the pump. “If undetected issues are present in
Drugs
FDA has released a final guidance entitled “Charging for Investigational Drugs Under an IND Questions and Answers.” The document outlines requirements in agency regulations that allow sponsors to charge for investigational drugs under an IND for both clinical trials and expanded access for treatment use. It supersedes FDA’s 2016
FDA Policy/General
Federal Register notice: FDA is announcing the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program. The program provides agency regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) firsthand exposure to industry’s drug development processes and (2)
FDA Policy/General
FDA’s Medical Devices Advisory Committee Circulatory System Devices Panel has voted 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs the risks for the treatment of people with tricuspid regurgitation (TR). An FDA briefing document said the pivotal trial’s
Drugs
The CDER Office of Scientific Investigations (OSI) completed 128 medical product-related clinical inspection summaries (consults) in support of user fee applications received from 24 of the 27 CDER clinical review divisions during Fiscal Year 2023. The OSI annual report says the consults resulted in 418 inspectional observations, 351 with
Drugs
CBER has issued a Standard Operating Policy and Procedure (SOPP), Section 505(o)(4) Required Safety Labeling Changes, as a guide for Center staff for requiring a Section 505(o)(4) safety labeling change. The document applies to NDAs and BLAs. The SOPP says that under the FDA Amendments Act
Drugs
After more than 12 years, FDA has approved a Public Citizen 8/7/2011 petition request for safety labeling changes for glucocorticosteroids administered orally and by injection. In its 2/8 response, the agency denied other petition requests. “In particular,” the response says, “we partially grant the request that FDA
Drugs
A 10/11-10/22/2022 FDA inspection at the Madhu Instruments Private Limited drug manufacturing facility in New Delhi, India, found that redacted drug products were adulterated in that they had been prepared, packed, or held under insanitary conditions in which they may have been contaminated with filth or
Drugs
An FDA review of records submitted by Ningbo Poplar Daily-Use, a manufacturer of over-the-counter drugs in Yinzhou, Ningbo, China, in response to an agency request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/5 Warning Letter says specific violations were:
FDA Policy/General
The FDA Office of Digital Transformation (ODT) has posted the FDA Information Technology (IT) Operating Plan, described as a “milestone in the agency’s technological evolution.” An online post (contains a link to the plan) says the plan sets forth strategies and initiatives to enhance service delivery to the public.
Drugs
FDA has approved an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorouracil, and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma. Approval was based on data from the company’s NAPOLI 3 trial (NCT04083235), a large-scale study involving 770 patients who had