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Filtering on: "topics business and leadership"

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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

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

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

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

FDA Begins Process of Overhauling Off-Label Communications Regulations By Zachary Brennan - Published 31 August 2016

The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Business and Leadership, Compliance, Drugs, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pharmaceutical off-label communications, Amarin, drug company free speech

FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal By Zachary Brennan - Published 30 August 2016

After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Labeling, Packaging, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NDCs, drug establishment registration, FDA drug lists, FDA rules, drug regulations

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

Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen By Zachary Brennan - Published 22 August 2016

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: News, US, FDA, FTC, Business and Leadership, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders

Reflections on Mergers and Acquisitions in the Healthcare Product Industry By Mark Gordon, MS, RAC, FRAPS, Sue James, RAC, FRAPS, Steven Knapp, MS, PharmD, Rosanne Yetemian, PhD, MSRS, RAC, Daniel G. Mannix, PhD - Published 18 August 2016

This article outlines critical process points, seven reflections from recent Merger and Acquisition (M&A) experiences and suggests best practices for optimizing M&A due diligence from several perspectives. In addition, the article offers insight and guidance on how to act, what to look for in due diligence exercises and what areas to further explore as one partakes in due diligence activities. The content was adapted from a session at the RAPS 2015 Regulatory Convergence in Baltimore, Maryland.

Categories: Features, Business and Leadership, Business Skills, Due Diligence

Tags: Mergers and Acquisitions, M&A, Due Diligence

Cancer Immunotherapies: EMA to Hold November Workshop By Zachary Brennan - Published 16 August 2016

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

Categories: News, Europe, US, EMA, FDA, Business and Leadership, Clinical, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: CAR T, CAR T-cell therapies, immuno-oncology, immunotherapy, EMA workshop on immunotherapies

FDA Issues Form 483 for Alexion’s Rhode Island Site By Zachary Brennan - Published 08 August 2016

Rare disease drugmaker Alexion disclosed late Monday in an SEC filing that the US Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of the company’s Smithfield, Rhode Island manufacturing facility and issued a Form 483 with three observations.

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

Tags: Alexion, rare disease, Rhode Island drug manufacturing, Soliris

Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays By Zachary Brennan - Published 04 August 2016

Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its moneymaker.

Categories: News, US, FTC, Business and Leadership, Generic drugs, Regulatory intelligence

Tags: Provigil, Cephalon, Teva, pay for delay

Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016) By Nick Paul Taylor - Published 26 July 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDSCO, stent prices, vaccine storage, Indonesia vaccines

UDI Form and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 25 July 2016

The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule.

Categories: News, US, FDA, Business and Leadership, Labeling, Medical Devices, Postmarket surveillance, Submission and registration

Tags: unique device identifier, UDI, UDI guidance, FDA draft guidance

The Next PDUFA: New Performance and Procedural Goals By Zachary Brennan - Published 15 July 2016

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022.

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

Tags: PDUFA VI, FDA user fees, FDA performance goals 2016