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Filtering on: "topics government affairs"

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Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

Maryland House Passes Bill on Price Gouging of Generic Drugs By Zachary Brennan - Published 21 March 2017

Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: price gouging, pharmaceutical price legislation, Maryland drug price gouging

Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017) By Nick Paul Taylor - Published 21 March 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

Humacyte Receives First of FDA’s Regenerative Medicine Designations By Zachary Brennan - Published 20 March 2017

The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: RMAT designation, regenerative medicine, 21st Century Cures

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency By Zachary Brennan - Published 17 March 2017

At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Cummings, Sanders, drug prices, PBMs

European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017) By Nick Paul Taylor - Published 16 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Government affairs

Tags: PRAC, imaging agents, data protection, neutropenic enterocolitis

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, China heparin, House E&C, FDA investigations

EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines By Zachary Brennan - Published 15 March 2017

The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator.

Categories: News, Europe, EMA, Clinical, Prescription drugs, Government affairs

Tags: PTC Therapeutics, Translarna, Court of Justice of the European Union

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, CRLs, biosimilars

New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India By Zachary Brennan - Published 14 March 2017

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs

Tags: warning letters, API manufacturers, water and pharmaceuticals

Canada to Require Drugmakers to Publicly Disclose Drug Shortages By Zachary Brennan - Published 13 March 2017

Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.

Categories: News, Canada, Health Canada, Business and Leadership, Drugs, Ethics, Government affairs

Tags: drug shortages, Food and Drug Regulations

Regulatory Recon: Roche and Mylan Settle Dispute Over Herceptin Biosimilar; EMA Suspends Marketing of Four Contrast Agents for MRI Images (13 March 2017) By Zachary Brennan - Published 13 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Class II devices, 21st Century Cures, FD&C Act

FDA Considers Creating New 'Office of Patient Affairs' By Zachary Brennan - Published 13 March 2017

As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

Categories: News, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: patient engagement and FDA, PEAC, patient perspectives, FDA patient advice

AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017 By Zachary Brennan - Published 09 March 2017

Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: AdvaMed, device guidance, FDA guidance 2017

505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times By Zachary Brennan - Published 09 March 2017

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development.

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

Tags: 505(b)(2) pathway, new drug approvals, Tufts, approval times

European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (9 March 2017) By Nick Paul Taylor - Published 09 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs

Tags: counterfeit drugs, online pharmacies, pharmaceutical water

Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 By Zachary Brennan - Published 08 March 2017

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, Drugs, Government affairs, Manufacturing

Tags: PIC/S, GMP guidelines, regulatory affairs

Trump’s FDA Commissioner Choice Coming Soon By Zachary Brennan - Published 08 March 2017

Dr. Tom Price, secretary of the US Department of Health and Human Services, said in an interview this week that the new commissioner for the US Food and Drug Administration (FDA) and other health-related political appointees should be announced in the next week or so.

Categories: News, US, FDA, Due Diligence, Government affairs

Tags: FDA commissioner, Scott Gottlieb, Tom Price

Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes By Zachary Brennan - Published 08 March 2017

A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Research and development

Tags: pediatric cancer clinical trials, BPCA, PREA, pediatric clinical trials

Obamacare Repeal Bill Would Eliminate Tax on Device Companies By Zachary Brennan - Published 07 March 2017

Late Monday, the GOP unveiled its Obamacare replacement bill with at least one provision that medical device companies will like: a permanent repeal of the 2.3% medical device tax.

Categories: News, US, Government affairs, Medical Devices

Tags: Obamacare, ACA, ACHA, device tax