FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice” (OMB Control Number 0910-0543). FDA regulations require domestic and foreign establishments that recover, process,
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify the agency in writing. It is also requesting nominations such representatives. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.” The document provides FDA’s recommendations for clinical trials intended to establish clinical effectiveness and safety for such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments that will assist it in determining whether to establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. Historically, FDA has not reviewed the safety of novel excipients
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna (voretigene neparvovec-rzyl), indicated for treating patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The review period is 3,809 days, which includes 3,591 days that occurred during the testing
FDA Policy/General
The Medical Information Working Group (MIWG) says FDA should include recent Supreme Court First Amendment free speech decisions in its ongoing analysis of manufacturer communications regarding unapproved uses of approved or cleared medical products. In a comment to the agency docket on the subject, MIWG says FDA should ensure that
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 Oncologic Drugs Advisory Committee meeting. During the morning session, the committee will discuss an AstraZeneca supplemental NDA for Lynparza (olaparib) tablets, indicated for maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: American Contract Systems, Houston, TX (11/9): FDA inspected the firm in September and found Quality System Regulation violations with various surgical
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Amgen’s Aimovig (erenumab-aooe), indicated for preventing migraines in adults. The regulatory review period is 2,042 days, which includes 1,675 days that occurred during the testing phase and 367 days during the
FDA Policy/General
Two weeks after sailing though his confirmation hearing (see earlier story), the Senate Health, Education, Labor & Pensions Committee 12/3 voted 18 to 5 to advance Stephen Hahn’s nomination to serve as FDA commissioner to the full Senate for consideration. “Dr. Hahn has extensive medical and research experience
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for drug clinical trials. It describes important principles for designing, conducting, and reporting the results from an adaptive clinical
FDA Policy/General
A Ropes&Gray legal analysis says that a recent Supreme Court decision on deference to agencies such as FDA that are interpreting their own regulations has changed the landscape and empowered plaintiffs. “Although FDA will often continue to receive deference in cases involving application of its specialized scientific knowledge
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Crysvita (burosumab-twza), indicated for treating X-linked hypophosphatemia in adult and pediatric patients. The regulatory review period is 3,485 days, which includes 3,241 days that occurred during the testing phase
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Under Section 515A of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 21 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novo Nordisk’s Ozempic (semaglutide), indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. The regulatory review period is 3,336 days, which includes 2,
FDA Policy/General
Tzvi Lexiere Debarred for 10 Years Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. 11/27/2019 Six ANDAs Withdrawn by FDA Federal Register notice: FDA withdraws approval
FDA Policy/General
Wave Life Sciences has entered into a research, license and option agreement with Pfizer to investigate developing nucleic acid therapies aimed at silencing the underlying causes of debilitating metabolic diseases. “The collaboration will focus on genetically defined targets and bring together Wave’s proprietary stereopure drug development platform, across antisense
FDA Policy/General
Federal Register notice: FDA has debarred Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. Lexier was also convicted on one felony count for unlicensed wholesale distribution of prescription drugs. To view the notice,
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document provides recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human
FDA Policy/General
The Justice Department says that a Puerto Rico federal grand jury has returned an indictment against Rubén Vázquez-Diaz, charging him with three counts each of introducing misbranded animal drugs, introducing adulterated animal drugs, mail fraud, and wire fraud, and one count of being a drug user in possession of