FDA Resources:

What’s New:

October 30, 2014: “Last week, the European Medicines Agency (EMA) released a final guideline containing new recommendations on how to bring biosimilar products to market in the EU. ”

Guideline: FDA Guideline

October 29, 2014: “Today, FDA launched the webpage for its Drug Quality Sampling and Testing Programs.  The webpage details quality, standards and outcomes, and testing results for fiscal years 2013 and 2014. ”

Program Webpage: http://www.fda.gov/Drugs/ScienceResearch/ucm407277.htm

“The FDA announced the approval of Wyeth Pharmaceuticals’ Trumenba, the first vaccine approved in the US for the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroup B in individuals between 10 and 25 years of age.”

News Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

October 24, 2014: “This week, FDA announced that warning letters will not be issued to manufacturers that volunteer to be inspected under the Medical Device Single Audit Program (MDSAP) unless a significant threat to public health is uncovered.  The goal of MDSAP is to allow manufacturers to undergo one audit by an accredited third party to satisfy quality regulations for the US, Canada, Brazil, and Australia.”  (The Silver Sheet)

October 17, 2014: “The FDA announced the approval of new labeling for Pfizer’s Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

Read the full press release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm

October 10, 2014: “Today, FDA announced the availability of a draft guidance for industry and FDA staff entitled, “Flow Cytometric Devices.”  The draft guidance document is intended to address certain issues that arise in premarket submissions for flow cytometric devices used as in vitro diagnostic devices for leukocyte immunophenotyping and provides suggestions on the content of submissions for these types of devices. ”

Read the full draft guidance here: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdf

Today, the FDA announced the availability of a guidance for industry entitled, “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.”

Read the full draft guidance here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf


October 8, 2014: A report prepared by the Staff of the Global Legal Research Center was released concerning the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available.

Read the full report here: http://www.loc.gov/law/help/medical-devices/approval-of-medical-devices.pdf

October 7, 2014: ” Today the FDA announced the availability of a draft guidance for industry entitled, “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.”

Read the draft guidance here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417568.pdf

October 2, 2014: “Potential tests to help doctors diagnose influenza sooner and more accurately will advance in development under contracts from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The tests could help boost influenza pandemic preparedness by increasing diagnostic capabilities in near-patient care settings such as doctors’ offices, clinics, and hospitals.”

Read the full press release here: http://www.hhs.gov/news/press/2014pres/10/20141001a.html