Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on the procedures the Center will use to determine whether a risk evaluation and mitigation strategy (REMS) for a prescription drug product marketed under an NDA or BLA is needed to ensure that the drug’s benefits outweigh its risks.
Drugs
A 6/16 petition submitted to FDA by Dr. Francis E. O’Connell, Jr., asks the agency to adopt language in the Boxed Warning and package insert for opioids that reflects the 9/2019 HHS Guidance for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.
Biologics
Luciana Borio, who was FDA acting chief scientist and served on the National Security Council in the Trump administration, says FDA needs to work to regain public trust after its missteps involving the emergency use authorization for hydroxychloroquine and chloroquine and allowing unapproved serology tests into the country. Interviewed for
Biologics
FDA has approved an Ultragenyx Pharmaceutical and Kyowa Kirin supplemental BLA for Crysvita (burosumab) for treating fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients two years of age and
Drugs
FDA has approved a label update for Almirall’s Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for developing resistance to sarecycline. This information is included in the Microbiology Section (12.4) of the prescribing information, the company says. Seysara, which was approved 10/2018, is described
Devices
FDA has approved the expansion of a U.S. pilot study of the USGI Medical POSE 2.0 non-invasive endoscopic procedure to evaluate weight loss for adults suffering from obesity and an obesity-related comorbidity. The company says POSE 2.0 uses the USGI incisionless operating platform to strategically
Drugs
A $16 million partnership between the Defense Advanced Research Projects Agency and Harvard University is aimed at narrowing down which medication, approved by FDA, is effective for treating Covid-19 patients. The UK’s International Business Times reports the collaboration is working “with the help of cutting-edge computational drug
Drugs
FDA has granted Epizyme accelerated approval for Tazverik (tazemetostat), an EZH2 inhibitor for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an agency-approved test and who have received at least two prior systemic therapies, and for adult
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” The document is the first in a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information
Drugs
FDA has issued an immediately-in-effect guidance, Statistical Considerations for Clinical Trials During the Covid-19 Public Health Emergency, to address the impact of Covid-19 on meeting trial objectives for clinical trials conducted during the duration of the public health emergency. The document outlines considerations for the statistical
Drugs
The Council for Responsible Nutrition (CRN) is asking FDA to establish a regulatory pathway to legally market dietary supplements containing hemp-derived cannabidiol (CBD). The 6/16 petition says Congress and industry have repeatedly requested that FDA use the authority granted to it by Congress to allow CBD to be
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number0910-0883). FDA intends to conduct research to understand better the challenges and opportunities encountered by the outsourcing facility sector in a number
Drugs
The citizen watchdog group Accountable.US says it is concerned about a lack of transparency from the Justice Department (DoJ) in its investigation of alleged price-fixing of generic drugs by Teva. In a 6/16 letter to attorney general William Barr, the group says it is concerned “since the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on its Pharmacy Compounding Advisory Committee. The panel provides advice on scientific, technical, and medical issues concerning human drug compounding. To view the notice, click here.
Devices
FDA has posted template updates for the validation of molecular diagnostic tests to be used by developers who intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having Covid-19. An agency online statement says the template updates are “a meaningful
Devices
FDA has revoked the emergency use authorization of Chembio Diagnostic System’s antibody test, DPP Covid-19 IgM/IgG System, due to performance concerns with the accuracy of the test. The serological test, which is intended to assess a person’s exposure to Covid-19, was one of the first
Devices
FDA says it has sent Warning Letters to three companies for marketing adulterated and misbranded Covid-19 antibody tests. An agency notice says the letters went to Mediakit Ltd., Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus and Sunrise Family Dental, doing business as My
FDA Policy/General
University of California San Francisco resident surgeon Nisarg Patel says FDA should be restructured as an independent agency to help protect it from the political pressures that have affected it for several decades and have been particularly obvious during the Covid-19 pandemic. Writing in a Politico opinion column, Patel
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) for treating active non-radiographic axial spondyloarthritis (nr-axSpA). Approval was based on data from the PREVENT trial, which met the primary endpoints “achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40%
Devices
FDA has announced a 9/30 virtual public meeting entitled “Patient-Reported Outcomes (PROs) and Medical Device Investigations: From Conception to Implementation.” The meeting is intended to discuss the benefits and challenges of incorporating patient perspectives in regulatory decision making using PRO instruments. The meeting is part of CDRH’s
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Data To Support Drug Product Communications as Used by the Food and Drug Administration” (OMB Control Number 0910-0695). The collection supports agency outreach efforts. FDA says testing of communication messages in advance of a communication campaign
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Protection of Human Subjects and Institutional Review Boards; Certificates of Confidentiality” (OMB Control Number 0910-0130). The Cures Act broadened the protections by prohibiting certificate holders from disclosing such information unless a specific exception applies. The revision