Search Results for PhRMA

Showing 1 – 25  of 55

Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System By Zachary Brennan - Published 17 October 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: News, US, Drugs, Reimbursement

Tags: pharmaceutical pricing, Senate HELP committee, PhRMA

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

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

PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals By Zachary Brennan, Michael Mezher - Published 11 April 2017

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: First Cycle Reviews, PhRMA, PDUFA V, PDUFA VI

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals By Zachary Brennan - Published 08 November 2016

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, citizen petitions, generic drug approvals

PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals By Zachary Brennan - Published 24 August 2016

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, BIO, PDUFA VI, Prescription Drug User Fee Act

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA

PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition By Zachary Brennan - Published 21 January 2016

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Submission and registration

Tags: biosimilar labels, US biosimilar market, Omnitrope, PhRMA, BIO

Industry Calls for Clarity, Phased Approach for Quality Metrics By Michael Mezher - Published 04 December 2015

Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy

Tags: Quality Metrics, PhRMA, GPhA, BIO

Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance By Michael Mezher - Published 04 November 2015

Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Preclinical, Regulatory strategy

Tags: Orphan drugs, Natural history studies, PhRMA, BIO, NORD

ICH Makes Organizational Changes By Zachary Brennan - Published 26 October 2015

The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law.

Categories: News, Japan, Canada, Europe, US, EMA, FDA, PMDA, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ICH, PhRMA, EFPIA, PMDA, EMA, FDA

Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity By Zachary Brennan - Published 05 October 2015

Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.

Categories: News, Asia, Canada, Oceania, US, Biologics and biotechnology, Distribution, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: TPP, Trans-Pacific Partnership, biologics exclusivity, BIO, PhRMA, MSF

Quality Metrics: Industry Reaction to FDA's Draft Guidance By Michael Mezher - Published 25 August 2015

On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy

Tags: Quality metrics, Inspections, Office of Pharmaceutical Quality, PhRMA, GPhA

PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting By Michael Mezher - Published 15 July 2015

The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, FDA, Biologics and biotechnology, Communication, Drugs, Submission and registration

Tags: PDUFA, PDUFA VI, PDUFA reauthorization, PhRMA

Biologics Exclusivity Still Central in Trade Talk Debate By Michael Mezher - Published 05 June 2015

The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history.

Categories: News, Asia, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, biologics exclusivity, regulatory data protection, PhRMA, intellectual property, IP, patents

Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System By Alexander Gaffney, RAC - Published 30 March 2015

In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks.

Categories: News, US, CDER, Drugs, Labeling

Tags: Generic Drug Labeling, Generic Drug Safety, Expedited Agency Review, EAR, PhRMA, GPhA

Trade Group Wants to See Stricter Limits on Compulsory Licensing By Michael Mezher - Published 02 March 2015

A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015, the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need.

Categories: News, Asia, Europe, Latin America and Caribbean, US, Drugs, Government affairs, Regulatory strategy

Tags: Compulsory License, TRIPS, Intellectual Property, PhRMA, US Trade Representative

Pharmaceutical Companies Look to Create Better Compassionate Use Process Published 11 December 2014

The prominent US pharmaceutical trade group PhRMA has released an updated set of principles it says reflects the US pharmaceutical industry's "commitment" to provide patients with life-threatening diseases access to investigational therapies on a compassionate-use basis.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Compassionate Use, Expanded Access, PhRMA, PhRMA Expanded Access Principles

Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further Published 28 August 2014

Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication.

Categories: News, US, CDER, Biologics and biotechnology, Prescription drugs, Labeling

Tags: PhRMA, Reprint Guidance, First Amendment, Free Speech, Guidance, Draft Guidance

FDA Releases PhRMA Proposal on How Drug Names Could be Reserved Prior to Launch By Alexander Gaffney, RAC - Published 21 August 2014

US regulators have finally released the text of a 2009 industry proposal that is set to form the basis of discussion at an upcoming meeting on whether companies should be allowed to "reserve" drug names for late-stage investigational drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling

Tags: PhRMA, Draft Guidance, Drug Naming, Drug Name, Drug Name Reservation

On the Heels of FDA Investments, PhRMA Funds Regulatory Science Initiative By Alexander Gaffney, RAC - Published 05 June 2014

In recent years, the US Food and Drug Administration (FDA) has made substantial investments in regulatory science initiatives, spending millions on research, establishing new academic programs, and partnering with dozens of institutions in the pursuit of new ways to bring safe and effective drugs to market more quickly.

Categories: News, US, Drugs

Tags: Regulatory Science, Fellowship, CERSI, PhRMA

PhRMA: Recommended Language in FDA Accelerated Drug Labeling Guidance Misleading By Alexander Gaffney, RAC - Published 02 June 2014

Pharmaceutical industry trade group PhRMA has come out forcefully against language contained within a draft guidance document issued in March 2014 by the US Food and Drug Administration (FDA), calling the agency's take on labeling drugs granted accelerated approval potentially confusing to patients and undercutting faith in the regulatory system.

Categories: News, US, FDA, Prescription drugs, Labeling

Tags: PhRMA, Guidance, Accelerated Approval, Draft Guidance, Labeling, Conditional Approval

PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Electronic Submissions, BIO, PhRMA, Latest News, eCTD, guidance