Drugs
Sens. Ron Wyden (D-OR), Rand Paul (R-KY), and Jeff Merkley (D-OR) have introduced legislation to ensure hemp-derived CBD (cannabidiol) products are regulated by FDA like other legal products used in dietary supplements, foods, and beverages. A joint statement (contains links to the bill text and bill
FDA Policy/General
FDA’s Office of Medical Policy clinical methodologies group has received a $9.2 million HHS grant to fund expansion of the CURE ID platform to allow automated data collection from electronic health records worldwide and clinical disease registries for Covid-19 and other difficult-to-treat infectious diseases. An
Drugs
Federal Register notice: FDA has made available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention. The document provides recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. It was developed to detail a recent change in agency recommendations on the necessary evidence
Drugs
International business management consultancy Sedgwick says that while product recalls, including drugs and medical devices, have dropped during the pandemic, there is likely to be a surge in recalls as businesses return to more normal operating conditions. In a statement, Sedgwick says that in the first quarter of 2021, medical
Drugs
FDA says a Web site maintained by NeuroHydrate, Bridgeport, CT, is selling HM-Formula, which is legally considered to be an unapproved new drug intended for use in the cure, mitigation, treatment, or prevention of disease. A just-released 4/27 Warning Letter cites many of the claims made for
Drugs
FDA has lifted a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma. Trial protocols have been amended to further reduce the incidence of Grade 3 or greater cytokine release syndrome during step-up dosing, the company says, adding
Drugs
FDA says it is implementing an interim process to communicate issues identified following a review of records or other information requested in lieu or in advance of a pre-approval or pre-license inspection for CDER regulated products. An agency online notice, Manufacturing, Supply Chain, and Drug Inspections, says FDA
Drugs
FDA acting commissioner Janet Woodcock says the Covid-19 pandemic has revealed issues with the clinical trial system in the U.S. that need to be addressed. In an interview with Outsourcing Pharma, she says there are gaps in the clinical trial infrastructure that could be overcome by creating a
Drugs
FDA says Bio-Botanica/Nature’s Answer’s Coral Calcium, that contains cesium chloride as a dietary ingredient and is labeled as a dietary supplement, is adulterated because cesium chloride is a new dietary ingredient. A 5/5 Warning Letter says there is no information demonstrating that cesium chloride was
Drugs
Four cancer researchers say that while the Covid-19 pandemic affected all clinical trials in the early waves of the disease, the impact on oncology trials was less severe compared with non-oncology trials. “As vaccines continue to be rolled out,” they write in an online Nature article, “we expect
Drugs
FDA has issued a final guidance entitled COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry. The document provides recommendations on master protocols evaluating drugs for treating or preventing Covid-19. An agency notice defines a master protocol as a “protocol designed with
Drugs
FDA has posted a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency — Questions and Answers. The revision answers questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. The
Drugs
FDA says it wants to improve its interactions among external stakeholders and experts, and its own scientists to advance regulatory science. Writing in an online post, FDA chief scientist and Denise Hinton and Office of Regulatory Science and Innovation (ORSI) director Tina Morrison update stakeholders on its Advancing Regulatory Science:
Drugs
FDA has taken the rare step of publicly correcting misinformation being disseminated by a drug company about an investigational therapy. In a 5/17 notice, FDA says two CytoDyn trials evaluating leronlimab do not support the drug’s clinical benefit in treating Covid-19 despite public company statements suggesting otherwise.
Drugs
Idaho attorney general Lawrence Wasden has announced that an agreement was reached between all 50 states and Indivior that requires it to pay $300 million to settle allegations that the company falsely and aggressively marketed/promoted Suboxone (buprenorphine), which resulted in improper Medicaid expenditures. Last year, Indivior pleaded guilty to
Drugs
The International Council for Harmonization is challenging the usefulness of two-year rat studies in a just-released Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals S1B(R1). The document expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach
Drugs
FDA has released its summaries from five GDUFA 3 reauthorization meetings. The summaries with discussion topics were: * March 25 – Continued clarifying discussions around shared proposals related to drug master files; FDA proposals to streamline annual reporting commitments; the role of inspections in meeting the requirements for a complete review; and
Drugs
A Baltimore Sun op-ed column written by two students at the NYU School of Law and a Yale University physician calls on whoever is named as FDA’s new commissioner to commit to enforcing clinical trial transparency. “Doing so is simple, requires no congressional action, and will meaningfully protect
Drugs
FDA has approved a Heron Therapeutics NDA for Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. HTX-011is described as a dual-acting,
Drugs
University of Connecticut Department of Pharmacy Practice head C. Michael White says FDA may have become too dependent on industry user fees and is not sufficiently funded for work not covered by those fees. In an online column at The Conversation, White traces the history of FDA funding from full
Drugs
FDA has accepted for review a Strongbridge Biopharma NDA for Recorlev (levoketoconazole) for treating endogenous Cushing's syndrome. The agency has set a user fee review action target date of 1/1/2022. The submission is based on data from the Phase 3 SONICS and LOGICS studies, which the
Drugs
The CDER Office of Surveillance and Epidemiology (OSE) 2020 annual report covers activities in the four core functions assigned to OSE — pharmacovigilance, pharmacoepidemiology, medication error prevention, and risk management. The report notes the Covid-19 pandemic poses particular challenges to OSE and it is using its full array of tools