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Filtering on: "topics government affairs"

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EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 By Zachary Brennan - Published 28 April 2017

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

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

Tags: Brexit, EMA headquarters, EMA move

Senate Committee Advances Gottlieb Nomination as FDA Commissioner By Zachary Brennan - Published 27 April 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

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

Tags: Gottlieb, Senate FDA, FDA commissioner

Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London By Zachary Brennan - Published 24 April 2017

With an eye to avoiding public health issues during a transition period, executives from Novartis, Pfizer, Eli Lilly, Amgen and other companies are calling on the European Council to decide on the new headquarters location of the European Medicines Agency (EMA) “as early on as possibly, preferably at its meeting in June.”

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

Tags: Brexit, EMA headquarters

FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray By Zachary Brennan - Published 24 April 2017

As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can revive those who have overdosed on opioids.

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

Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone

Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines By Zachary Brennan - Published 20 April 2017

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

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

Tags: codeine, tramadol, label changes

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

MHRA Investigates GMP Deficiency Trends From 2016 By Zachary Brennan - Published 18 April 2017

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs).

Categories: News, Europe, MHRA, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP deficiencies, pharmaceutical inspections, GMP deficiency trends

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

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

Tags: J&J, Pfizer, Allergan, combination products and FDA

Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees

Regulatory Recon: Drug Shortages Can Spur Price Increases for Similar Drugs (13 April 2017) By Zachary Brennan - Published 13 April 2017

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

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

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

European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017) By Nick Paul Taylor - Published 13 April 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, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EpiPens, House of Lords, drug pricing, EMA guidance

FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements By Zachary Brennan - Published 12 April 2017

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements.

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

Tags: 21 Century Cures, Class I devices, medical devices

Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco By Zachary Brennan - Published 12 April 2017

Goa, India-based contract manufacturer Indoco Remedies received a US Food and Drug Administration (FDA) warning letter late last month after the agency said its failure to comply with current good manufacture practices (CGMP) may significantly affect the quality, safety and efficacy of the drugs it manufactures.

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

Tags: FDA warning letter, Indoco Remedies, cGMP

FDA Warns Mylan Over Quality System Failures By Zachary Brennan - Published 11 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 3 April to Mylan Pharmaceuticals for its Nashik, India-based manufacturing site, which FDA said does not have a functioning quality system.

Categories: News, India, US, FDA, Drugs, Government affairs, Manufacturing

Tags: Mylan, ARVs, LMIC, HIV, Mylan India

AdvaMed CEO Confident of Device Tax Repeal This Year By Michael Mezher - Published 11 April 2017

The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: AdvaMed, Medical Device Tax, Inspections

Strategies Adopted by Innovator Companies in Response to Biosimilars Competition By Charu Manaktala, MD, MBBS, Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 10 April 2017

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension

EMA Board Adopts New Policy on Whistleblowing By Zachary Brennan - Published 10 April 2017

With an aim to encourage whistleblowers and others to feel safe coming forward with possible details of improprieties, the European Medicines Agency’s (EMA) Management Board on Monday adopted a new policy detailing how the agency handles such allegations, including those that could have an impact on the evaluation and supervision of medicines.

Categories: News, Europe, EMA, Compliance, Crisis management, Government affairs

Tags: whistleblower, EMA policy, OLAF, clinical trial whistleblowing

‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs By Zachary Brennan - Published 10 April 2017

A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs.

Categories: News, US, FDA, Distribution, Generic drugs, Government affairs

Tags: generic drug bill, pay for delay, REMS, delaying generic drug entry

Maryland Lawmakers Pass Generic Drug Price Gouging Bill By Zachary Brennan - Published 10 April 2017

Maryland lawmakers on Monday sent a bill that would seek to increase transparency and prevent generic drug price gouging to Gov. Larry Hogan (R) for his signature.

Categories: News, US, Drugs, Government affairs

Tags: drug price gouging, Maryland pharmaceuticals, Hogan, Brian Frosh

European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017) By Nick Paul Taylor - Published 06 April 2017

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

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

Tags: EU clinical trials, trial endpoints, EMA guideline

A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers By Zachary Brennan - Published 06 April 2017

As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: Form 483, FDA inspection reports, API manufacturing

European Parliament Calls for Rapid Relocation of EMA Headquarters By Zachary Brennan - Published 06 April 2017

The European Parliament on Wednesday called for an agreement to be reached “as quickly as possible” to relocate the headquarters of the European Medicines Agency (EMA) following the UK’s decision to exit the EU.

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

Tags: Brexit, EMA, European Parliament, Kent Woods

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