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Federal Register notice: FDA has withdrawn approval of Hikma International Pharmaceuticals’ abbreviated new animal drug application for 1-gram bolus of phenylbutazone in horses because the product is no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FDA has posted a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.”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
Drugs
FDA is requesting additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the company’s Phase 1-2 IGNITE DMD clinical trial that is evaluating SGT-001 in Duchenne muscular dystrophy. The hold was originally placed 11/2019 after the company reported a serious
Devices
FDA has reissued an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use — testing for people who do not have Covid-19 symptoms or who have no reason to suspect Covid-19 infection, and to allow pooled sample testing. The
Devices
FDA has cleared a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for relieving pain. The company says Vesta was developed to treat pain in clinical scenarios where its Nimbus® RF Multitined Expandable Electrode, which provides a large volume lesion for
FDA Policy/General
Federal Register notice: FDA has issued a 10-year debarment order against Jin Su Park from importing or offering for import any drug into the U.S. The action is based on Park being convicted of one felony count under federal law for importing misbranded drugs. To view the notice,
FDA Policy/General
Federal Register notice: FDA has issued a debarment order permanently debarring Euton M. Laing from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on Laing’s 8/2019 conviction for criminal conspiracy against the regulation of a
FDA Policy/General
Federal Register notice: FDA has issued a 10-year debarment order against John Seil from importing or offering for import any drug into the U.S. The action is based on 2019 felony convictions for distributing male sexual enhancement pills that he marketed as herbal remedies but that contained undisclosed
FDA Policy/General
An investor consortium led by AGIC Capital has agreed to acquire U.S. pharmaceutical firm Ritedose Corp. from private equity firm Olympus Partners. The transaction will help AGIC to expand its customer base and identify business opportunities in China, and the rest of Asia. Ritedose is headquarted in Columbia, SC
Drugs
FDA has approved an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease. Approval was based on data from the Phase 3 ETHOS trial that demonstrated Breztri Aerosphere had a statistically significant reduction in the rate of moderate or