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
FDA Policy/General
The U.S. House of Representatives has passed an FDA spending bill that sets the agency’s 2021 discretionary funding at $3.212 billion, an increase of $40.8 million (less than 1% increase) above the 2020 enacted level. Total funding for the agency, which includes user fees, is $5.
Devices
Guided Therapeutics has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan. According to the protocol, the company says LuViva will be studied to assess its ability to help detect a significant number of the up to 40% to 50% of cervical cancer
Biologics
Israeli researchers who looked at 57 vaccines approved by FDA between 1/1/1996 and 12/31/2015 report that the vaccines were found to be “remarkably safe” over the period. “A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance,
Drugs
In a letter to JAMA Internal Medicine published 7/27, CDER director Janet Woodcock and two of her Center colleagues defend the agency’s use of so-called integrated reviews from concerns that they won’t meet the agency’s goals and may introduce new problems. With the modernized reviews,
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of Hikma International Pharmaceuticals’ abbreviated new animal drug application for 1-gram bolus of phenylbutazone in horses because the product is no longer manufactured or marketed. To view the notice, click here.
Drugs
FDA has posted a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s recommendations for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two
Devices
FDA has published a guidance, Multiple Function Device Products: Policy and Considerations, to explain the agency’s regulatory approach and policy for all multiple function device products. Specifically, the document clarifies when and how FDA intends to assess the impact of “other functions” that are not the subject of a
Drugs
A 1/13-1/17 FDA inspection at Eosera, Inc., Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/13 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
An 11/12-11/25/19 FDA inspection at Tender Corp., Littleton, NH, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s production of over-the-counter unapproved and misbranded new drugs. A 7/23 Warning Letter says specific violations were: * failing to ensure that
Biologics
CBER says that American Medical Aesthetics and Regenerative Medicine, Inc., Irvine, CA, markets an unlicensed “stem cell therapy” product that is derived from umbilical cord and may be administered by injection into joints or muscle or infused by IV into blood. A 7/22 Notice of Violation says the company
FDA Policy/General
Federal Register notice: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications made during January, February and March. FDA is making available summaries of the basis of approval and environmental review documents, where applicable. To view
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eosera, Inc., Fort Worth, TX (7/13): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, Eosera failed to thoroughly investigate any
Biologics
Moderna says it has begun dosing participants in a Phase 3 study of its mRNA vaccine candidate (mRNA-1273) for Covid-19. The COVE (Coronavirus Efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority under
Drugs
Indivior Solutions has pleaded guilty to one felony count and agreed to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment Suboxone (buprenorphine). An earlier $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group, and