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Filtering on: "topics submission and registration"

Showing 1 – 25  of 465

The Prescription Drug User Fee Act (PDUFA): A Primer By Valerie Fauvelle, MS, RAC, Meredith Brown-Tuttle, RAC, FRAPS - Published 25 April 2017

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

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

Tags: User Fees, Prescription Drug User Fee Act, PDUFA

Health Canada to go eCTD-only for Drug Applications By Michael Mezher - Published 25 April 2017

Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.

Categories: News, Canada, Health Canada, Drugs, Submission and registration

Tags: Electronic Common Technical Document, eCTD

EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: QbD pilot, EMA-FDA joint program, quality by design

TGA to Move Forward With Orphan Drug Revamp By Michael Mezher - Published 18 April 2017

Australia's pharmaceutical industry is "broadly supportive" of proposed changes to the country's orphan drug program, the Therapeutic Goods Administration (TGA) says.

Categories: News, Oceania, TGA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Orphan Drugs, Australia

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

EMA Updates Guidance on Clinical Data Publication Policy By Michael Mezher - Published 14 April 2017

The European Medicines Agency (EMA) on Wednesday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect last fall.

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

Fast Start for FDA Drug Approvals in 2017 By Michael Mezher - Published 12 April 2017

The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015.

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

Tags: Approvals, New Molecular Entities, Biologics License Applications

PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals By Zachary Brennan, Michael Mezher - Published 11 April 2017

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.

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

Tags: First Cycle Reviews, PhRMA, PDUFA V, PDUFA VI

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

Biosimilar Intellectual Property Issues in the US: An Update By Raymond A. Huml, MS, DVM, RAC, Allen R. Baum, JD, Jill Dawson, PhD - Published 07 April 2017

This article provides an update on US biosimilar intellectual property issues in areas including the complex and evolving areas of patent protection, market exclusivity, the 'patent dance,' and lifecycle planning.

Categories: Features, US, FDA, Biologics and biotechnology, Submission and registration

FDA Delays eCTD Requirements for Master Files By Michael Mezher - Published 07 April 2017

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.

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

Tags: drug master files, biological product file, DMF, BPF, electronic common technical document, eCTD

EU Parliament Adopts New Medical Device, IVD Regulations By Michael Mezher - Published 05 April 2017

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: MDR, IVDR, European Parliament

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Submission and registration

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

MHRA to No Longer Require Payment in Advance for License Applications By Michael Mezher - Published 31 March 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced changes to how it handles payments for license applications for drugs and clinical trials.

Categories: News, Europe, MHRA, Clinical, Drugs, Submission and registration

Tags: Fees, Payment

Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges By Shahid Hussain, RPh, PharmD - Published 30 March 2017

This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs.

Categories: Features, Compliance, Drugs, Quality, Submission and registration

Tags: DRAP, Drug Regulatory Authority of Pakistan

European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017) By Nick Paul Taylor - Published 30 March 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, Regulatory intelligence, Submission and registration

Tags: EMA guideline, antibiotics, animal health

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

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

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