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Filtering on: "topics business and leadership"

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'Historic Action': FDA Approves First CAR-T Therapy By Zachary Brennan - Published 30 August 2017

The US Food and Drug Administration (FDA) on Wednesday approved the first gene therapy, Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: News, US, FDA, Business and Leadership, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Kymriah, CAR-T, gene therapy, FDA approved gene therapies

Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018 By Zachary Brennan - Published 28 August 2017

Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements.

Categories: News, US, FDA, Business and Leadership, Compliance, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug user fees, medical device user fees, MDUFA IV, GDUFA II

Resources and Training for Regulatory Professionals By Sofia Campos Silva, MSc, PharmD - Published 27 July 2017

This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.

Categories: Features, Business and Leadership, Career Development, Regulatory intelligence

Regulatory Career Progression By Kamila Kawiak, Kavita Patel - Published 17 July 2017

This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.

Categories: Features, Business and Leadership, Career Development, Career Search

Tags: Career Development, Regulatory Profession

Generic Industry Group Sues Maryland Over Price Gouging Law By Zachary Brennan - Published 06 July 2017

The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly.

Categories: News, US, Business and Leadership, Generic drugs, Government affairs

Tags: AAM, generic drugs, Maryland drug price gouging law

Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

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

New Study Says 63% of US Adults Trust FDA By Zachary Brennan - Published 17 May 2017

A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them.

Categories: News, US, FDA, Business and Leadership, Communication, Drugs, Government affairs

Tags: FDA public opinion, CDC

BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices By Zachary Brennan - Published 15 May 2017

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.

Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act

FDA Hedges: A Proposal to Better Share R&D Risks By Zachary Brennan - Published 19 April 2017

The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval process.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics

Tags: R&D risk, pharmaceutical risks, FDA hedges

FDA Commissioner Nominee Faces Limited Opposition From Senate Committee By Zachary Brennan - Published 05 April 2017

The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Business and Leadership, Government affairs

Tags: Scott Gottlieb, FDA commissioner, Senate HELP hearing

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

European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017) By Nick Paul Taylor - Published 16 February 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, Business and Leadership, Government affairs

Tags: European regulatory roundup, biosimilars, Brexit

‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations By Zachary Brennan - Published 30 January 2017

President Donald Trump on Monday morning signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted.

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

Tags: OMB, hiring freeze, executive order on regulations, Trump, Trump regulations, EO on regs

European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017) By Nick Paul Taylor - Published 26 January 2017

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

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit, Theresa May, NICE Chair

EMA Reveals List of Eligible Industry Stakeholder Organizations By Zachary Brennan - Published 16 January 2017

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

Categories: News, Europe, EC, EMA, Business and Leadership, Government affairs

Tags: drug industry stakeholders

FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section By Zachary Brennan - Published 08 December 2016

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

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

Tags: DSCSA, track and trace, supply chain pharmaceuticals, FDA guidance

Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway By Zachary Brennan - Published 07 December 2016

Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away.

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

Tags: Obamacare, ACA, biosimilars, Bill Cassidy

Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes By Zachary Brennan - Published 06 December 2016

Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes.

Categories: News, US, Biologics and biotechnology, Business and Leadership, Drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: pharmaceutical price transparency, drug prices, increases in drug prices, Vermont pharmaceuticals, Medicaid

Mylan CEO Defends EpiPen Price Increases By Zachary Brennan - Published 01 December 2016

Mylan CEO Heather Bresch on Thursday defended the more than 400% price increase for its life-saving EpiPen, saying the company has made the device “more ergonomic” and that patients “never see the needle.”

Categories: News, US, Business and Leadership, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EpiPen, Mylan, Heather Bresch, generic drug price gouging

Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016) By Zachary Brennan - Published 16 November 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, DOJ, EMA, FDA, FTC, MHRA, NICE, PMDA, TGA, Biologics and biotechnology, Business and Leadership, Clinical, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

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

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following By Zachary Brennan - Published 16 November 2016

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written.

Categories: News, Asia, Europe, US, Advertising and Promotion, Biologics and biotechnology, Business and Leadership, Communication, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Twitter, regulatory affairs, regulatory intelligence

What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains By Zachary Brennan - Published 14 November 2016

For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.

Categories: News, Europe, EC, Business and Leadership, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ANSM, CE marking, notified bodies

FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak By Zachary Brennan - Published 12 October 2016

An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia, in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.

Categories: News, US, FDA, Business and Leadership, Compliance, Crisis management, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: bacterial outbreak, CDC, PharmaTech, US drug manufacturing

GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info By Zachary Brennan - Published 29 September 2016

Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data.

Categories: News, US, FDA, Business and Leadership, Postmarket surveillance, Project management

Tags: IT security, non-public data and FDA