FDA Resources- September 2014

What’s New:

September 29, 2014: “The FDA has announced plans to publish 13 new product-specific guides for device makers. Check out the latest at: http://www.fdanews.com/

September 26, 2014: “The NIH and FDA win top awards for intellectual property licensing of meningitis vaccine.”

Read the full press release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416282.htm

September 24, 2014: “Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.”

Read the full press release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm

September 15, 2014: “Today,  the FDA announced the withdrawal of a draft guidance for industry and FDA staff entitled, “Class II Special Controls Guidance Document: External Pacemaker Pulse Generator,” dated October 2011.

Read the full FR Notice here: http://www.gpo.gov/fdsys/pkg/FR-2014-09-15/pdf/2014-21815.pdf

September 12, 2014: “Today, FDA announced it is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene.

Read the full FR Notice here: http://www.gpo.gov/fdsys/pkg/FR-2014-09-12/pdf/2014-21729.pdf

September 10, 2014: “Today the FDA published the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).

The FDA reminded health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, TX.

Read the full press release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413506.htm

September 2, 2014: “Today, FDA issued a final rule reclassifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls).  The device is intended to detect the EGR1 probe target on chromosome 51 in bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).”

FR Notice: http://www.gpo.gov/fdsys/pkg/FR-2014-09-03/pdf/2014-20882.pdf

HHS contracts with Mapp Biopharmaceutical to develop Ebola drug: “The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract supports the governmentwide response to the Ebola outbreak in West Africa.”

Full article here: http://www.hhs.gov/news/press/2014pres/09/20140902b.html