FDA Policy/General
FDA officially has a new commissioner after Robert Califf was sworn in 2/17. Earlier in the week, the U.S. Senate narrowly voted 50 to 46 to approve Califf’s confirmation (see earlier story). “The Senate made the right move this week by confirming Dr. Califf to lead the
Devices
FDA has cleared a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app. The company says this is the only FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. “The
FDA Policy/General
Federal Register notice: FDA is soliciting comments about antimicrobial drug use practices in companion animals and the potential impacts on antimicrobial resistance in both humans and animals. The comments will help the agency develop and implement a strategy for promoting antimicrobial stewardship in companion animals. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a 5/9-10 public workshop entitled “FY 2022 Generic Drug Science and Research Initiatives Workshop” that will provide an overview of science and research initiatives for generic drugs and an opportunity for public input on the initiatives. To view the notice, click here.
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-8 on 2/15 that Avenue Therapeutics did not submit adequate information to support its position that the benefits of IV tramadol outweighed its risks in managing acute pain
Biologics
CBER says it has “substantially increased” its international efforts in addressing the Covid-19 pandemic, including regulatory and research collaborations on Covid-19 vaccine and convalescent plasma products. An online overview report says that by “providing scientific and regulatory strategies to facilitate the development, authorization, and availability of Covid-19
Drugs
Attorney Marc Ullman (Rivkin Radler) questions a push for mandatory dietary supplement listing with FDA in light of what he sees as the agency’s failure to enforce existing dietary supplement laws and regulations. In an online post for Natural Products Insider, Ullman writes that for at least eight years
FDA Policy/General
The Department of Justice says a Florida man has pleaded guilty to one count of conspiracy to violate the anti-kickback law. A department statement says Anderson Triggs, Palm City, FL, conspired with others from 2014 through 2016 to use Main Avenue Pharmacy, Clifton, NJ, to run a kickback scheme
Biologics
FDA has granted Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older. The designation was made based on preliminary clinical evidence showing that the vaccine candidate
Biologics
FDA has granted a Regenerative Medicine Advanced Therapy designation to a gene therapy developed by University of California San Francisco researchers to treat Artemis-SCID. The designation means the research is considered promising and will be expedited for development and review. The university says Artemis-SCID is a severe form
FDA Policy/General
Federal Register notice: FDA has announced a 3/10 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear an overview of research programs in CBER’s Gene Transfer and Immunogencity Branch. A closed session will follow for committee deliberations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations notify the agency if they are interested in participating in selecting voting industry representatives to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. To view the notice, click here.
Drugs
Two Dechert attorneys say the 9/2021 FDA “intended use” regulation should not keep companies from manufacturing more of a drug or medical device than they would need to meet the anticipated demand for on-label prescriptions because it was aware of off-label uses. Writing in a Washington Legal
FDA Policy/General
Federal Register notice: CDER and CBER are announcing that 2/15 is the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide, and 3/15 is the date that this version update is required in
Drugs
A pilot program that could improve drug development and approval for rare diseases is part of the performance goals outlined for the upcoming PDUFA reauthorization. Medill News Service reports the pilot would be expected to bolster clinical trials for rare diseases by increasing collaboration between industry and the agency to
Drugs
AstraZeneca says it “welcomes FDA’s provision of clear guidance on the inspection of injectable products for visible particulates.” The company’s response to an agency draft guidance on the topic also includes line-by-line specific comments. Boehringer Ingelheim’s response says the intent and overall goal of the
Drugs
FDA has accepted a Mirati Therapeutics NDA for adagrasib to treat patients with non-small-cell lung cancer with the KRASG12C mutation who have received at least one prior systemic therapy. The company says the PDUFA action date was set at 12/14. The NDA is being reviewed for accelerated
Drugs
An 8/2-8/7/21 FDA inspection at Indiana Chem-Port, Vadodara Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A 2/2 Warning Letter says the deviations were: * failing to ensure that equipment surfaces in contact with APIs do not
Drugs
A 7/12-7/26/21 FDA Bioresearch Monitoring Program inspection at Avila Herbals, Christiansburg, VA, determined that the owner/clinical investigator did not follow applicable legal requirements governing the conduct of clinical investigations and the protection of human subjects. A 2/4 Warning Letter cites these issues: * failing to
FDA Policy/General
Federal Register notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the United States’ position on the proposals that will be discussed at a meeting of the United
Drugs
FDA has placed a clinical hold against Legend Biotech and its Phase 1 clinical trial for LB1901, an investigational autologous chimeric antigen receptor T-cell therapy targeting malignant CD4+ T-cells for treating adults with relapsed or refractory T-cell lymphoma. The agency notified the company by email and indicated
FDA Policy/General
The U.S. Senate voted 2/15 to confirm Robert Califf as the next FDA commissioner by a slim-margin vote of 50 to 46. He previously served as FDA head during the last year of the Obama presidency in 2016 after clearing the Senate in an 89-4 vote.