FDA Policy/General
Federal Register Notice: FDA is making available a guidance document: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271. It provides establishments that manufacture HCT/
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use. It provides a statement of qualification for exploratory use for
Devices
Repro-Med says that some of the inspection observations from 6/2015 cited in a recent Warning Letter from FDA’s New York District Office had already been resolved to the agency’s satisfaction and three observations require additional clarification. Company officials say they are in the process of addressing
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans. It revises the draft guidance entitled Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study
FDA Policy/General
Federal Register Notice: FDA and the Drug Information Associations will co-sponsor a public conference entitled Tenth Annual DIA/Food and Drug Administration Statistics Forum — 2016. It is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 5/2 entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The meeting will be held from 8:30 a.m. to 5 p.m. at FDA's White Oak Campus, 10903
Drugs
Pernix Therapeutics is asking FDA to refuse to approve any ANDA or relevant 505(b)(2) NDA citing Pernix’ Zohydro ER (hydrocodone bitartrate) extended-release capsules as the reference-listed drug if the applicant proposes to omit from the labeling certain safety-related information that is protected by patent. In
Drugs
Amarin Pharma has submitted to a New York federal court a proposed settlement in its case against FDA over commercial speech about off-label use of its Vascepa. Under the proposal, FDA would agree to be bound by the court’s conclusion at trial that the company may engage in
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are asking FDA and HHS officials for information on the progress they have made in adding the unique device identifier (UDI) of medical devices to health insurance claims forms to improve post-market surveillance and curb Medicare waste. Their 3/
Drugs
An electronic submissions update at a recent DIA regulatory submissions, information, and document management forum indicated that there were 14,700 electronic submission gateway submissions to CDER in 12/2015, making it the highest month ever for electronic submissions. CDER Division of Data Management Services and Solutions director Ginny Hussong
Devices
FDA has cleared a Cepheid 510(k) for the Xpert Carba-R, an in vitro diagnostic test for identifying distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP. “The emergence of carbapenemase producing organisms, known as
Drugs
FDA has lifted a partial clinical hold against a Medivation IND for pidilizumab (MDV9300) in hematological malignancies and confirmed that a Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, as well as other studies that cross reference the IND, may now proceed. The
FDA Policy/General
Federal Register Notice: FDA will hold a public hearing 5/20 that will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders — industry,
FDA Policy/General
FDA deputy commissioner for foods and veterinary medicine Michael R. Taylor will be leaving the agency 6/1 to look for work involving food security in developing countries. “I’m not retiring,” he told FDA Webview firmly, though he said he could not be more specific yet about exactly where
Devices
FDA has accepted for review a Vericel BLA for MACI (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended for treating symptomatic cartilage defects of the knee in adult patients. The agency has set a user fee review target date of 1/3/2017. Additionally, the company
Drugs
Health care stakeholders participating in an Academy of Managed Care Pharmacy (AMCP) forum reached agreement on recommendations to make it easier for pharmaceutical companies to share pharmacoeconomic information with health care organizations that make coverage decisions. The forum was held 3/1-2 in Washington, DC, and sought to clarify
Drugs
CDER has posted a draft guidance on “Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome (PRO), for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease (COPD): Qualification for Exploratory Use.” The document says the Center has determined that evaluating respiratory symptoms
Devices
FDA is alerting healthcare professionals about magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The agency says it has analyzed peer-reviewed literature, device labeling, adverse event medical device reports, and information from ICD manufacturers, health care organizations,
Drugs
The LIGHT trial to determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events was terminated early after an unplanned release of confidential interim data by the sponsor (Orexigen) and the results “remain uncertain and will require evaluation in a new adequately powered outcome trial,” according to
FDA Policy/General
FDA says it is proposing to research the use of superimposed text in direct-to-consumer DTC) drug ads. A Federal Register notice says that the proposed study is intended to extend previous research on the effects of such text in general print and TV advertising to today’s modern
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures (MAPP) on scoring configuration of generic drug products. The document says that consistent scoring assures that patients are able to adjust the drug’s dose by breaking a generic drug in the same manner as the
Biologics
FDA has issued a guidance, Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, to give establishments that manufacture human cells, tissues, and cellular and