FDA Policy/General
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram say the agency is taking new steps to put in place modern regulations that foster innovation in plant and animal biotechnology through a new Plant and Animal Biotechnology Innovation Action Plan. “This new plan advances policy priorities that FDA will pursue
FDA Policy/General
Federal Register notice: FDA has opened a public docket to receive suggestions and comments on the agency’s publication of its surrogate endpoint table (SE table). FDA has developed a Web page that displays the SE table, describes the purpose of the table, and provides additional background information. Comments received
FDA Policy/General
Federal Register notice: FDA’s chief scientist has denied a request for a hearing on a CDER proposal to refuse approval of a Pharmaceutical Manufacturing Research Services (PMRS) NDA for oxycodone hydrochloride immediate-release oral capsules. The notice summarizes the grounds for not approving the submission. On 11/16/2017,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Boule Medical Stockholm, Sweden (10/2): FDA inspected the firm and cited GMP deficiencies with its Medonic M-Series Hematology Analyzer. For example, the firm failed to establish and
FDA Policy/General
Federal Register notice: FDA has announced a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee. On 12/4, the committee will discuss, make recommendations, and vote on an Impulse Dynamics PMA for the Optimizer Smart Implantable Pulse Generator, indicated to provide cardiac contractility modulation for Class
FDA Policy/General
Federal Register notice: FDA has classified the active implantable bone conduction hearing system into Class 2 (special controls). FDA’s action was based on a 2/2017 MED–EL Elektromedizinische Geraete request for de novo classification of the BoneBridge, which is identified as a prescription device consisting of an implanted
FDA Policy/General
Federal Register notice: FDA has classified high-flow humidified oxygen delivery devices into Class 2 (special controls). FDA’s action is based on a 1/2017 Vapotherm de novo classification request for its Precision Flow HVNI, which is identified as a prescription device that delivers high flow oxygen with humidification
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Novo Nordisk’s Rebinyn (coagulation factor IX recombinant) glycopegylated), indicated for use in adults and children with hemophilia B. The regulatory review period has been determined to be 2,793 days, which includes 2,
FDA Policy/General
Info Collection Extension for REMS Requirements Federal Register notice: FDA seeks comments on an information collection extension entitled “Prescription Drug Product Labeling; Medication Guide Requirements.” 10/26/2018 Comment Period Reopened on Sucralfate Guide Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a revised draft product-specific guidance on sucralfate that appeared in a 10/20/2017 notice. The reopening is in response to two citizen petitions and the agency has determined that the petitioners and other stakeholders can submit comments by
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Biopharmaceutics Classification System-Based Biowaivers” that was prepared by the International Council for Harmonization. The document provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of in vivo bioequivalence studies for
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Eli Lilly’s Taltz (ixekizumab), indicated for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The regulatory review period was determined to be 3,036 days,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug Product Labeling; Medication Guide Requirements” (OMB Control Number 0910-0393). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Testicular Toxicity: Evaluation During Drug Development.” The document addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect, and quarantine and disposition of a
FDA Policy/General
Federal Register notice: FDA has awarded a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revcovi (elapegademase-lvlr) injection meets the award criteria. The product is approved for treating adenosine deaminase-severe combined immunodeficiency in pediatric and adult patients. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. The committees will be asked to provide input and advice on strategies to increase the availability of naloxone products intended for use in communities.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Imclone’s Lartruvo, indicated for combination use with doxorubicin for treating adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable
FDA Policy/General
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram reviewed 20 years of FDA history in a 10/24 speech to the JAX Healthcare Forum “to illustrate how innovation is truly part of FDA’s DNA. FDA plays an important role in the biomedical ecosystem, working with scientists,
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Genentech’s Tecentriq (atezolizumab), indicated for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its guidance on “Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products.” The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Wyeth’s Besponsa (inotuzumab ozogamicin), indicated for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The regulatory review period was determined to be 5,298 days, which included 5,057