The primary purpose of the subcommittees is to gather information, conduct research, or analyze relevant issues and facts in preparation for meetings by the Working Group, or to draft position papers for deliberation by the Working Group.
The 2017-2018 PHEMCE Strategy and Implementation Plan (PDF, 986 KB) provides the blueprint for the PHEMCE to enhance national security through the development, procurement, and planning for effective use of critical medical countermeasures (MCMs).
The PHEMCE Multiyear Budget (PDF, 1.8 MB) shows how much HHS agencies are spending or plan to spend over a five-year period to develop, review, and stockpile medical countermeasures. FDA-specific information begins on page 36.
Zika update for HCT/P establishments
Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission in Hidalgo County, Texas
On December 19, 2017, CDC added new epidemiological information on its Blood and Tissue Safety webpageused to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community. Specifically, CDC reported that local, mosquito-borne transmission of ZIKV began in Hidalgo County, Texas on September 1, 2017.
January 11, 2018: Antimicrobial Drugs Advisory Committee public meeting (Hyattsville, MD) - The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
New!January 11, 2018:FDA Grand Rounds - Ethnicity- and Gender-related Differences in Alzheimer’s Disease, presented by Sherry Ferguson, PhD, Research Psychologist and Vijayalakshmi Varma, PhD, Research Biologist, FDA National Center for Toxicological Research (NCTR) - CE credit available
New!April 17-20, 2018: Preparedness Summit (Atlanta, GA) - The theme for the conference is Strengthening National Health Security: Mastering Ordinary Responses, Building Resilience for Extraordinary Events. Registration is now open. (fee)
MERS-CoV diagnostic update: FDA granted a de novo request (PDF, 226 KB) from BioFire Diagnostics, LLC for its FilmArray Respiratory Panel 2 plus (RP2plus), a multiplexed nucleic acid test intended for use with FilmArray 2.0 or FilmArray Torch systems for the simultaneous qualitative detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple common viral and bacterial respiratory pathogens. This assay is intended to test nasopharyngeal swabs obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria; if patients do not meet these criteria, this test should not be used. Existing MERS-CoV diagnostic Emergency Use Authorizations (EUAs) remain in effect. (November 24, 2017)
Draft guidance - Drug Products, Including Biological Products, that Contain Nanomaterials (PDF, 235 KB), to provide recommendations to industry engaged in developing human drug products in which a nanomaterial is present in the finished dosage form, including recommendations regarding investigational, premarket, and postmarket submissions for these products. Comment by March 19, 2018. (December 18, 2017)
Reminder: The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)requests proposals for projects that address technology and/or workforce development issues in biomanufacturing. Only NIIMBL members may participate on proposal project teams. Organizations must provide a signed Membership Agreement by January 12, 2018 to submit a proposal or be included on a project team. Also see the full RFP (PDF, 448 KB)
What is gene therapy and how does it work? Scientists have been working on the process for decades. Now this research on gene therapy is finally paying off with FDA approving three gene therapy products, the first of their kind, in 2017. Video - 1:30 (December 19, 2017)
How does FDA protect public health? Take this training course to learn about the drug regulatory process and earn free CE.
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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