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Filtering on: "topics regulatory strategy"

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EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias By Zachary Brennan - Published 21 September 2017

Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.

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

Tags: EU ombudsman, early regulator engagement, pre-submission meetings

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

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

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars By Zachary Brennan - Published 21 September 2017

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

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

Tags: biosimilar guidance, analytical similarity, FDA guidance

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: REMS, Hatch-Waxman, generic drug competition

Biomarker Qualification: FDA Explains Process and Opportunities for Engagement By Michael Mezher - Published 19 September 2017

In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.

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

Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures

Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September By Gloria Hall - Published 06 September 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Categories: Features, FDA, Health Canada, Biologics and biotechnology, Generic drugs, Medical Devices, Regulatory strategy, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

FDA Finalizes Guidance on Interoperable Devices By Zachary Brennan - Published 05 September 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: interoperable medical devices, EHRs and devices

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 By Zachary Brennan - Published 31 August 2017

The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, ICH, MHRA, WHO, Drugs, Regulatory intelligence, Regulatory strategy

Tags: IPRF, IGDRP, pharmaceutical regulations

Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.

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

Tags: medical device advisory committee meetings

'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

FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions By Zachary Brennan - Published 30 August 2017

The US Food and Drug Administration (FDA) has finalized a slightly tweaked guidance on medical device companies’ use of real-world data (RWD) and real-world evidence (RWE) in winning approvals for their products.

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

Tags: real world evidence and medical devices, real world data and FDA

MHRA Offers Interactive Guide on New EU Device, IVD Regulations By Zachary Brennan - Published 29 August 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).

Categories: News, Europe, EC, MHRA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, EU device regulations

FDA to Unveil New Regulatory Framework for Stem Cell Therapies By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency this fall will advance a new framework to regulate stem cell therapies.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: stem cell therapy, FDA on regenerative medicine, DTC stem cell clinics

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

EMA and FDA to Begin Sharing Commercially Confidential Information By Zachary Brennan - Published 23 August 2017

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will now share non-public and commercially confidential information, including trade secret information.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II By Zachary Brennan - Published 22 August 2017

Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).

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

Tags: FDARA, GDUFA, pre-submission guidance

Pfizer Wins Indian Patent on Prevnar 13 Vaccine By Zachary Brennan - Published 22 August 2017

India’s patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims.

Categories: News, Asia, Europe, US, Crisis management, Drugs, Regulatory strategy

Tags: Prevnar 13, Pfizer, PCV, pneumonia vaccine

FDA Offers Draft Guidance to Further Secure Drug Supply Chain By Zachary Brennan - Published 21 August 2017

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging, Regulatory strategy

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

Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 By Zachary Brennan - Published 21 August 2017

President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDARA, FDA user fees, user fee reauthorization, medical product reviews

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market By Zachary Brennan - Published 15 August 2017

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.

Categories: News, US, FDA, Drugs, Ethics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf

How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs By Zachary Brennan - Published 15 August 2017

As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop.

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

Tags: priority review vouchers, biodefense, medical countermeasures

Apple Continues Push Into Device Industry With New Patent Filing By Zachary Brennan - Published 14 August 2017

Last week, tech behemoth Apple signaled its interest in further pursuing the development of medical devices with a new patent granted for an electronic device that "computes health data."

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

Tags: Apple, iPhone, mHealth, digital health

New Research Compares Drug Regulators Around the Globe By Zachary Brennan - Published 11 August 2017

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: News, Asia, Canada, Europe, US, Anvisa, CFDA, EMA, FDA, MHRA, PMDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers

Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar By Zachary Brennan - Published 10 August 2017

The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

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

Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen