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Filtering on: "topics government affairs"

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AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: News, US, FDA, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

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

Categories: News, Asia, CDSCO, CFDA, ICH, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

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

Tags: generic drugs, priority review of generics, drug price competition, drug prices

FDA, NCI to Collaborate Further on Cancer Research By Zachary Brennan - Published 26 June 2017

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: News, US, CDRH, Combination products, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: National Cancer Institute, proteogenomics, cancer research

Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure By Michael Mezher - Published 23 June 2017

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

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

Tags: Brexit, EMA Relocation

Senate Health Bill Would Repeal Device Tax By Michael Mezher - Published 22 June 2017

Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law.

Categories: News, Government affairs, Medical Devices

Tags: Medical Device Tax

Regulating CRISPR: FDA and Industry Offer Perspective By Zachary Brennan - Published 21 June 2017

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

CBO Releases Cost Estimate for User Fee Bill By Michael Mezher - Published 19 June 2017

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Government affairs, Medical Devices, Submission and registration

Tags: CBO, User Fees, Reauthorization

Application of EU Clinical Trial Regulation Delayed to 2019 By Zachary Brennan - Published 16 June 2017

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

Categories: News, Europe, EC, EMA, Clinical, Compliance, Government affairs

Tags: EMA clinical trial regulation, clinical trial regs, EMA portal

WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

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

Tags: digital health, FDA digital health, software as a medical device

FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

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

Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017) By Nick Paul Taylor - Published 13 June 2017

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

Categories: News, Asia, CDSCO, CFDA, Crisis management, Drugs, Government affairs

Tags: Asia Regulatory Roundup, India clinical trials, CFDA guidance

Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? By Zachary Brennan - Published 12 June 2017

The Senate Health, Education, Labor & Pensions (HELP) committee is holding a hearing Tuesday on prescription drug costs and will look to address how the drug delivery system affects what patients pay.

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

Tags: Senate HELP, Mylan, Valeant, Turing, drug prices

US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval By Zachary Brennan - Published 12 June 2017

The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Business and Leadership, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supreme Court of the United States, SCOTUS, biosimilars, patent dance

Qualification of Drug Development Tools: FDA Updates Process By Zachary Brennan - Published 08 June 2017

Thanks to the 21st Century Cures Act, there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which can include biomarkers, animal models and clinical outcome assessments.

Categories: News, US, CDER, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: DDT, drug development tools, biomarkers, clinical outcome assessments

EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms By Zachary Brennan - Published 31 May 2017

The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: small- and medium-sized pharmaceutical companies, EMA on SMEs

Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017) By Zachary Brennan - Published 31 May 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Health Canada, NICE, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

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

European Commission and EMA Offer Guidance on Brexit for Pharma Companies By Zachary Brennan - Published 31 May 2017

As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in EU member states, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU.

Categories: News, Europe, EC, EMA, Crisis management, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, QPPV, PSMF, batch release, orphan products, MAHs and Brexit

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization By Zachary Brennan - Published 26 May 2017

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: antimicrobial resistance, antibiotic resistance, new antibiotics

Copaxone Generics: Who Will Win First Filer Exclusivity? By Zachary Brennan - Published 25 May 2017

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

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

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's

Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming By Zachary Brennan - Published 25 May 2017

US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations committee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed in the budget and revealed that FDA as of Thursday is no longer subject to a hiring freeze.

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

Tags: Scott Gottlieb, FDA budget 2018, FDA user fees, drug prices