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Filtering on: "topics regulatory strategy"

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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

EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25 By Michael Mezher - Published 26 May 2017

The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: PRIME, Priority Medicines

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 Establishes FDA Committee to Confront Opioid Crisis By Zachary Brennan - Published 23 May 2017

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

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

Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Keytruda, Merck, biomarkers, oncology approvals

EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events By Zachary Brennan - Published 22 May 2017

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders

Australia Considers Allowing the Marketing of Devices Approved Overseas By Zachary Brennan - Published 22 May 2017

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: News, Oceania, TGA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices

FDA Details How Kalydeco's Indication Expanded Without New Clinical Data By Michael Mezher - Published 19 May 2017

For the first time, the US Food and Drug Administration (FDA) has expanded a drug's indication without additional clinical data.

Categories: News, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: Kalydeco, Cystic Fibrosis

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017) By Nick Paul Taylor - Published 16 May 2017

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, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CFDA guidance, medical device prices in India, Australia drug ads

Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse By Zachary Brennan - Published 16 May 2017

Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse."

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

Tags: Scott Gottlieb, FDA commissioner, opioids, 21st Century Cures

EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 By Zachary Brennan - Published 15 May 2017

A majority of respondents to a European Commission questionnaire says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: HTA, health technology assessments, European Commission report

Congress to Trump: Let’s Tackle Drug Pricing in User Fee Reauthorizations By Zachary Brennan - Published 15 May 2017

As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office.

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

Tags: drug pricing, Trump, FDA user fees

FDA Officials Discuss Modernizing the Regulation of Combo Products By Zachary Brennan - Published 15 May 2017

As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature.

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

Tags: combination product regulation, combo products and FDA, 21st Century Cures

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 Signs Off on New Device to Treat Esophageal Birth Defect in Babies By Zachary Brennan - Published 12 May 2017

The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in their esophagus.

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

Tags: humanitarian device exemption, FDA device approvals

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

Senate Committee Advances FDA User Fee Reauthorization Bill By Zachary Brennan - Published 11 May 2017

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September.

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

Tags: user fee reauthorization, Senate HELP, Hatch, Franken, Collins, FDA user fees

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

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

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency By Zachary Brennan - Published 10 May 2017

With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PRIME, Brexit, EMA in 2016

FDA Science Board Weighs Plan for 'Cures' Funds By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA science board, Celgene, GSK, Amgen, 21st Century Cures

Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds By Zachary Brennan - Published 09 May 2017

Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: adverse events, significant safety events, postmarket studies

Biosimilars in the EU: New IMS Report Shows Savings Through Competition By Zachary Brennan - Published 09 May 2017

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: biosimilars, biologic competition, anti-TNF, HGH

FDA Warns Lonza’s Class II Device Manufacturing Site By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

Categories: News, US, CDRH, Biologics and biotechnology, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Lonza, medical device manufacturing, FDA warning letter