Login
Password
Sources on this Page

> Headlines by Category

 Home / Health / Drugs

You are using the plain HTML view, switch to advanced view for a more complete experience.

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
Audience: Risk Manager, Cardiology, Nursing [Posted 01/17/2018] ISSUE: FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is...
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
Audience: Pharmacy, Oncology, Nursing [Posted 01/16/2018] ISSUE: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have...
FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients...
Post Selected Items to:

Showing 10 items of 56

home  •   advertising  •   terms of service  •   privacy  •   about us  •   contact us  •   press release design by Popshop •   © 1999-2018 NewsKnowledge