FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The document explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, such as scientific necessity for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.” The document clarifies the scope of the law as it applies to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Biohaven Pharmaceutical’s Nurtec ODT (rimegepant sulfate), indicated for the acute treatment of migraine with or without aura in adults. The regulatory review period period is 3,390 days, of which 3,144 days occurred
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The survey is intended identify the barriers that prevent product developers from entering the pediatric device market as well as the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Abbreviated New Animal Drug Applications — Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). The collection
FDA Policy/General
Federal Register notice: FDA has renewed its Arthritis Advisory Committee for an additional two years. The new charter will be in effect until 4/5/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The template is intended to serve as a guided submission preparation tool for industry to improve submission consistency and enhance efficiency during the review process. The document provides further standards
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is taking comments on a proposal to study endorser status and actual use of a drug product in TV direct-to-consumer (DTC) ads. A Federal Register notice says the proposal would extend an OPDP study currently underway that is looking at
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is proposing two research studies on different aspects of drug promotion. A Federal Register notice says the first study will examine patient and healthcare provider perceptions about prescription drugs that have medication tracking capabilities. The notice says that to improve adherence to
FDA Policy/General
Former U.S. Attorney Gregory Brower says a 9/15 Department of Justice (DoJ) memo provides additional details on what will be an increased focus on corporate enforcement action. Writing in a Washington Legal Foundation Legal Pulse, Brower says the memo followed a presentation by deputy attorney general Lisa Monaco
FDA Policy/General
Federal Register notice: FDA has determined that GlaxoSmithKline’s prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, any generic product referencing prescription NIX would be
FDA Policy/General
Federal Register notice: FDA has announced an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (niraparib) capsules. Panel members will discuss the drug’s use for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who
FDA Policy/General
Harvard Medical School researchers say the federal government “has not exercised the full scope of its authority to prosecute corporate officials responsible for the illegal behavior of the drug and device companies they run.” Writing in JAMA Internal Medicine, the researchers say enforcement under a reinvigorated Responsible Corporate Officer doctrine
FDA Policy/General
Federal Register notice: FDA is requesting patient advocate applications for participation under its collaboration with the Clinical Trials Transformation Initiative’s Patient Engagement Collaborative (PEC). The PEC is an ongoing forum where the patient community and regulators are able to discuss an array of topics on increasing meaningful patient engagement
FDA Policy/General
Federal Register notice: FDA has determined that Hoffmann-La Roche’s Endep (amitriptyline HCl) oral concentrate, 40 mg/mL was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all legal and regulatory requirements are met. To view
FDA Policy/General
The Department of Justice (DoJ) says its top priority for corporate criminal enforcement is “individual accountability” by targeting the “individuals who commit and profit from corporate crime,” DoJ deputy attorney general Lisa O. Monaco said during a 9/15 program on corporate criminal enforcement in New York. To illustrate the
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride tablets and its use in controlling serum phosphorus levels in adults with chronic kidney disease on dialysis. Panel members will be asked to comment on whether
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Q3D(R2) Guideline for Elemental Impurities.” The International Council for Harmonization document provides recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products, and conducting risk assessments. To view the notice, click here.
FDA Policy/General
Federal Register notices: FDA has published three notices about its most recent periodic reassessment of the definition of ‘‘small number of animals’’ for minor use in major species. One notice announces that the small number of animals upper limit thresholds for horses and the food-producing major species (cattle, pigs,
FDA Policy/General
Federal Register notice: FDA has determined that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn due to safety or effectiveness reasons. Such a finding requires the agency to not accept or approve ANDAs (XXX PLURAL XXX)for the drug product. In 2019,
FDA Policy/General
Speaking 9/15 at an FDA/Organization for Economic Cooperation and Development workshop on illicit trade in health products, FDA associate commissioner Mark Abdoo challenged those present to consider what a global coalition that can explore opportunities for collaboration and identify concrete solutions, including at the policy level, might look
FDA Policy/General
Congressional negotiators are continuing to work on legislation to reauthorize FDA user fees. A Politico online newsletter reports that the Democratic and Republican leadership in the House Energy and Commerce Committee and Senate HELP Committee had aimed to reach a deal on 9/12, but talks have been extended to