Search Results for Pew

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BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding By Zachary Brennan - Published 14 June 2017

The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act. 

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: drug compounding, PhRMA, BIO, Pew Charitable Trusts, DQSA

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

Pew: Insurance Claims Must Include UDIs to Track Device Safety By Michael Mezher - Published 13 April 2016

The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care.

Categories: News, FDA, Medical Devices, Postmarket surveillance

Tags: Unique device identifier, UDI, claims forms, CMS, Pew Charitable Trusts, Josh Rising

Industry Weighs Integration of UDIs Into Medical Device Registry Network By Michael Mezher - Published 18 November 2015

The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Coordinated registry networks, CRN, Medical Device Registry Task Force (MDRTF), AdvaMed, Pew Charitable Trusts, Unique Device Identification, UDI

Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA By Alexander Gaffney - Published 28 March 2012

Categories: FDA, CDER, CDRH

Tags: BIO, Pew, Testimony, Shuren, GPhA, Woodcock, PhRMA, AdvaMed, Latest News, HELP, Congress, committee

Poll: Americans Widely in Favor of Prescription Drug Regulation By Alexander Gaffney - Published 01 March 2012

Categories: Drugs, Prescription drugs

Tags: Pew, Poll, Pharmaceuticals, Latest News, regulation, regulatory