Search Results for MOU

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Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says By Zachary Brennan - Published 09 January 2018

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: parallel review, Shuren, MOU

USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards By Zachary Brennan - Published 21 October 2015

The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things.

Categories: News, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality

Tags: USP, Roszdravnadzor, Russian drug regulation, MOU, laboratory audits

In Reversal, FDA to no Longer Publish Agreements in Federal Register By Alexander Gaffney - Published 21 August 2012

Categories: FDA

Tags: Federal Register, MOU, Published, Final Rule, Latest News

UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment' By Alexander Gaffney - Published 26 June 2012

Tags: Adverse Comment, MOU, Withdraw, Final Rule, Latest News, website

Brazil: Regulation Seen as Supporting Social And Economic Development By Ansis Helmanis, RegLink - Published 18 June 2012

Categories: Regulatory Update, Anvisa

Tags: MOU, brazil, regulatory

China: China Signs MOU with the Ukraine By Louise Zornoza, RegLink - Published 18 May 2012

Categories: Regulatory Update, China

Tags: Zakharash, Ukraine, MOU, Yin Li, SFDA, pharmaceutical, drug

China Signs MOU with the Netherlands Published 07 May 2012

Categories: Regulatory Update, China

Tags: breast implants, MOU, Netherlands, PIP

FDA Altering Policies on Publishing Memoranda of Understanding By Alexander Gaffney - Published 23 March 2012

Categories: FDA

Tags: Memorandum of Understanding, Memoranda of Understanding, MOUs, MOU, Latest News, website