Drugs
Eton Pharmaceuticals has submitted an NDA for zonisamide (previously known as ET-104) oral suspension for treating partial seizures in patients with epilepsy. Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA-approved in a liquid form. Eton says its patent-pending
Drugs
FDA says it is proposing to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with Section 503B of the Federal Food, Drug, and Cosmetic Act. An agency notice says the four substances are diphenylcyclopropenone, glycolic acid, squaric
Drugs
FDA has granted Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patients with higher-risk myelodysplastic syndromes. The company says the candidate therapy, a first-in-class NEDD8-activating enzyme (NAE) inhibitor, could be the first novel therapy for the indication in more than a
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format.” The document provides clarification and additional information on recommendations to applicants submitting NDAs, BLAs, and efficacy supplements to approved NDAs or BLAs. To
Devices
FDA says it is reminding patients and healthcare providers about the risk associated with using deep brain stimulation devices for Parkinson’s disease. “Patients may be at risk of injury during water-related activities (such as swimming) because of the loss of coordination while using the device,” an agency notice
Devices
FDA says the next in a series of Webinars on issues involving respirators and other personal protective equipment will be held 8/4 from Noon to 1 p.m. An agency notice said FDA, the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health, and
Drugs
FDA has approved the Roche Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast cancer and as a companion diagnostic for the company’s Herceptin (trastuzumab). The company says the assay is designed to be completed within the same day, enabling clinicians to get
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — Time and Extent Applications for Nonprescription Drug Products (21 CFR 330.14)” (OMB Control Number 0910–0688)
Biologics
CBER director Peter Marks told an online Disease Control and Prevention Summit that FDA could issue an emergency use authorization (EUA) for a Covid-19 vaccine in a matter of weeks once the vaccine’s efficacy requirements are met. CNN reports that Marks told the summit the increased attention FDA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s current recommendations about endotoxin limits and discusses a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in
FDA Policy/General
Federal Register notice: FDA has issued a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.” The document provides FDA’s regulatory approach for device products with multiple functions including at least one device function and includes such device
Drugs
FDA has published a guidance, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products, to describe the circumstances under which the agency generally does not intend to take action regarding required stability studies for the repackaged products and appropriate expiration dates under those circumstances. The document addresses
Drugs
FDA has published a draft guidance, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in complying with the content and format requirements for human drug and biological products labeling subsections on pregnancy, lactation, and females and males of reproductive
Drugs
FDA has published a guidance, Pathological Complete Response in Neoadjuvant Treatment of High-Risk, Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval, to assist sponsors in designing trials to support marketing approval of drugs and biological products for treating high-risk early-stage breast cancer in
Drugs
The Department of Justice (DoJ) says Pacira Pharmaceuticals will pay $3.5 million to resolve allegations that it paid kickbacks to doctors as bogus research grants to induce them to prescribe its Exparel (bupivacaine liposome injectable suspension) non-opioid analgesic. A DoJ statement says the allegations arose from a False
Devices
FDA has cleared a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system. The clearance allows for a new splint attachment which broadens Yomi’s application to include full arch implant cases as well as partially edentulous cases, according to the company. Neocis
Drugs
FDA has updated its inactive ingredient database (IID) that allows users to perform electronic queries to obtain accurate maximum daily exposure (MDE) information for excipients for each route of administration. “MDE is the total amount of the excipient that would be taken or used daily based on the maximum daily
Drugs
A Government Accountability Office (GAO) report says FDA officials believe that a new process for regulating over-the-counter drugs included in the CARES Act “could improve FDA’s ability to address identified safety risks in a more timely and efficient manner in the future.” GAO says the act “established
FDA Policy/General
Federal Register notice: FDA is announcing a 9/8-9 virtual meeting of its Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. On 9/8, panel members are scheduled to discuss and make recommendations on the classification of facet screws systems, which are currently unclassified pre-amendment
Devices
Two law professors say that FDA guidances on seeking emergency use authorizations for new Covid-19 tests contributed to the delay in rolling out tests and, because some agency actions were not supported by law, “FDA’s interference in areas Congress had not authorized the agency to regulate was an
Devices
FDA has posted a new template for commercial developers to help them develop and submit emergency use authorization requests for Covid-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab (e.g., offices or schools), and that could be available without a