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Filtering on: "topics submission and registration"

Showing 1 – 25  of 449

Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan By Satoshi Koike, PhD, DSc - Published 23 March 2017

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Common Technical Document, CTD

Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire By Michael Mezher - Published 22 March 2017

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: PDUFA VI, Prescription Drug User Fee Act

EMA Seeks Experts on Clinical Data Anonymization By Michael Mezher - Published 22 March 2017

The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Clinical Study Reports, Publication, Transparency, Anonymization

When to Submit a 510(k) (Devices and Software): A Regulatory Perspective By Jeff Ryberg - Published 21 March 2017

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

Categories: Features, US, FDA, Medical Devices, Submission and registration

Tags: 510(k), Software

Law Firm Challenges FDA on Combination Product Appeals By Michael Mezher - Published 09 March 2017

Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Citizen Petition, Request for Designation, 21st Century Cures Act

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR

GAO: Drugmakers Want More Clarity on Antibiotic Incentives By Michael Mezher - Published 03 March 2017

Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO).

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

Tags: Government Accountability Office, GAO, Generating Antibiotic Incentives Now, GAIN Act, Qualified Infectious Disease Product, QIDP

House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases By Michael Mezher - Published 02 March 2017

Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Submission and registration

Tags: OPEN Act, Marketing Exclusivity,

EMA Fees to Rise Beginning on 1 April By Michael Mezher - Published 28 February 2017

Beginning on 1 April 2017, the fees collected by the European Medicines Agency (EMA) from applicants and market authorization holders will increase by 1.2%, in line with the inflation rate in the EU for 2016.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Fees

FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework By Michael Mezher - Published 24 February 2017

Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions.

Categories: News, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Submission and registration

Tags: Real-world data, Accelerated approval

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

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

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics By Zachary Brennan - Published 20 February 2017

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

Categories: News, US, Biologics and biotechnology, Government affairs, Research and development, Submission and registration

Tags: biosimilars, GPhA, AAM, Biosimilars Council, Amgen, Sandoz

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

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

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition By Michael Mezher - Published 14 February 2017

The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence

May Deadline for FDA's eCTD Transition Approaches By Zachary Brousseau - Published 13 February 2017

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to FDA all New Drug Applications, Biologics License Application and Abbreviated New Drug Applications using the electronic Common Technical Document (eCTD).

Categories: HTML, Articles, Under RAPS, RAPS, Compliance, Generic drugs, Prescription drugs, Submission and registration

Tags: eCTD, electronic Common Technical Document, Submissions

Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February By Gloria Hall - Published 06 February 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 February.

Categories: Features, China, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, Biologics and biotechnology, Compliance, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles, Feature Summary

Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue By Zachary Brennan - Published 02 February 2017

Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote.

Categories: News, US, FDA, Clinical, Research and development, Submission and registration

Tags: historical control group, placebo, genetic marker, clinical benefit

Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada By Linda Bowen, MS, RAC, João Duarte, MPharm - Published 01 February 2017

This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Regulatory strategy, Submission and registration

Small Organizations, Big Regulatory Strategy By Angela Johnson, MSE, PMP, RAC - Published 30 January 2017

This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.

Categories: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Regulatory Strategy, SMEs

FDA Explains How GDUFA II Will Help Small Businesses By Zachary Brennan - Published 26 January 2017

The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first.

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

Tags: GDUFA II, generic drug user fees, CMO user fees

Strategies for Smarter Compliance in a Technology-Driven FDA Environment By Matthew M. Lowe - Published 26 January 2017

The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance.

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration

Tags: eCTD, Electronic Common Technical Document

EMA Reflects on its First Decade of Conditional Marketing Authorizations By Michael Mezher - Published 24 January 2017

Ten years after the development of the conditional marketing authorization (CMA) pathway, European Medicines Agency (EMA) on Monday said the program is working as intended, and has led to earlier patient access to 30 drugs, nearly half of which were for orphan indications, and 80% of which target seriously debilitating or life-threatening conditions.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Conditional Marketing Authorisation, CMA

Updated: FDA and EMA in 2016: A Look at the Numbers By Michael Mezher - Published 19 January 2017

The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: New active substances, New molecular entity, Approvals