Search Results for science

Showing 1 – 25  of 76

PMDA Head Talks Priorities for 'Rational Medicine' By Michael Mezher - Published 10 February 2017

The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.

Categories: News, Japan, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Tatsuya Kondo, Rational Medicine, Regulatory Science

European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016) By Nick Paul Taylor - Published 10 November 2016

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

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices

Tags: Brexit, Big Data, regulatory science, social media, adverse event reporting

GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics By Zachary Brennan - Published 27 October 2016

In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools.

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

Tags: GDUFA, generic drugs, FDA science priorities

A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances By Zachary Brennan - Published 18 October 2016

New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term.

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

Tags: emerging science, new FDA approaches to developing science, emerging technology

RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers By Zachary Brousseau - Published 06 September 2016

RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious, by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Max Sherman, science

The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends By Bob Clay, Chris Griffett, Gavin Outteridge - Published 29 July 2016

This article discusses how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity.

Categories: Features, EMA, FDA, NICE, Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy

Tags: Regulatory Science

GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals By Zachary Brennan - Published 15 June 2016

The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers.

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

Tags: GAO on FDA, regulatory science, FDA center communications

CDRH Unveils Top Regulatory Science Priorities for 2016 By Zachary Brennan - Published 20 October 2015

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, FDA, regulatory science, device cybersecurity, device safety

FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation By Zachary Brennan - Published 21 September 2015

The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board.

Categories: News, US, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: FDA Science Board, Science Looking Forward Subcomittee, US FDA, precision medicine, 21st Century Cures

Eight Years on, FDA Celebrates its Scientific Advancement By Michael Mezher - Published 03 August 2015

Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007.

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

Tags: Regulatory science, Science Board,

Japan Edges out FDA for Fastest Approvals By Michael Mezher - Published 31 July 2015

In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs).

Categories: News, Japan, Europe, US, EMA, FDA, MHLW, PMDA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: New drug approvals, New active substance, NAS, Centre for Innovation in Regulatory Science, CIRS, ICH, Orphan drugs, Expedited review, Priority Review

FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More By Alexander Gaffney, RAC - Published 24 February 2015

The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA).

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

Tags: BAA, Broad Agency Announcement, Regulatory Science

FDA Looking for a Leader for its New Device Testing Division By Alexander Gaffney, RAC - Published 04 November 2014

The US Food and Drug Administration (FDA) is on the hunt for a new leader for its device center's newly formed Division of Biology, Chemistry and Materials Science (DBCMS).

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: DBCMS, Dicision of Biology, Chemistry and Materials Science, Hiring

FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices By Alexander Gaffney, RAC - Published 14 August 2014

The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Research and development

Tags: MDDT, Medical Device Development Tools, Qualification, MDDT Pilot Program, Regulatory Science

Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following By Alexander Gaffney, RAC - Published 23 July 2014

How can regulatory professionals use Twitter as a tool to collect regulatory intelligence? This articles explains the basics of Twitter, as well as 460 accounts that life science professionals can follow to get started and make the most out of the social media platform.

Categories: News, Regulatory intelligence

Tags: Healthcare Social Media, Twitter, Social Media, Top Twitter Accounts, Top Twitter in Life Science, Top Twitter in Pharma, Top Twitter in Medical Device, Top Twitter in Biotech

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

FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics By Alexander Gaffney, RAC - Published 27 May 2014

The US Food and Drug Administration (FDA) has released its latest "Broad Agency Announcement" detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: Generic Drug, Regulatory Science, Broad Agency Announcement, Funding, Contracts

Two New Centers of Regulatory Science Excellence Launched by FDA By Alexander Gaffney, RAC - Published 07 May 2014

Categories: US, FDA

Tags: CERSI, Latest News, regulatory science

Sleep—Still a Mystery! By Max Sherman - Published 07 May 2014

Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains.

Tags: Effects of Sleep, Science of Sleep, Sleep, Science and Technology

Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: Regenerative Medicine, Cures Acceleration Network, CAN, Legislation, Latest News, regulatory science, Bill

A Case for Quality from an Industry Perspective By Max Sherman - Published 12 March 2014

The US Food and Drug Administration (FDA) recently has asked whether it has been using the right methods to improve device quality. This article is an introduction to the history of quality improvement and its implementation.

Categories: RAPS Events, FDA

Tags: History of Quality Improvement, Quality Improvement, Case for Quality, Science and Technology

FDA 's Marketing Pitch to Scientists: Come Work for Us By Alexander Gaffney, RAC - Published 04 February 2014

Categories: US, FDA

Tags: Science

FDA's Influential Science Board Seeks New Members By Alexander Gaffney, RAC - Published 31 January 2014

Categories: US, FDA

Tags: Science Board, Latest News, advisory committee

CDER Unveils Five-Year Plan Focused on Smart Regulation, Scientific Innovation and Lean Management By Alexander Gaffney, RF News Editor - Published 02 December 2013

Categories: US, FDA, CDER

Tags: Strategic Plan, regulatory science

FDA Says Focus on Regulatory Science Key to Advancing Personalized Medicine and Helping Patients By Alexander Gaffney, RF News Editor - Published 29 October 2013

Categories: US, FDA

Tags: Report, Approvals, Latest News, regulatory science, personalized medicine