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Filtering on: "topics submission and registration"

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House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations By Zachary Brennan - Published 17 November 2017

The Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis.

Categories: News, US, FDA, Crisis management, Regulatory strategy, Submission and registration

Tags: NDAA, emergency use authorization

Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways By Michael Mezher - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Devices Referencing Drugs, DRD, Combination Products

FDA Announces Third-Party Review Pathway for Tumor Profiling Tests By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Next-Generation Sequencing, NGS, Tumor Profiling Tests, MSK-IMPACT, New York State Department of Health, NYSDOH

Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017) By Nick Paul Taylor - Published 14 November 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Sets Monthly ANDA Records in October By Michael Mezher - Published 14 November 2017

The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).

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

Tags: ANDAs, GDUFA II, Complete Responses

Eight Key Steps Toward EU-MDR Implementation By Gert Bos - Published 13 November 2017

This article offers eight steps toward ensuring compliance with the new European Union Medical Device Regulations. It is based on the author's presentation given in July 2017 on "EU Regulatory Essentials, Medical Device, and In Vitro Diagnostics: Transitioning From Current Directives to new Regulations" at the RAPS Brussels Conference.1, 2

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

EMA, EUnetHTA Sign Off on Three-Year Work Plan By Michael Mezher - Published 13 November 2017

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

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

Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice

EMA Backs Six Drugs, One Biosimilar for EU Approval By Michael Mezher - Published 10 November 2017

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

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

Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi

TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices By Michael Mezher - Published 09 November 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.

Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration

Tags: 3D-Printing, Custom Medical Devices

FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions By Michael Mezher - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE).

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

Tags: ADRG, Analysis Data Reviewer's Guide, PhUSE

FDA Announces Streamlined Review Pathway for DTC Genetic Tests By Michael Mezher - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Genetic Health Risks, GHR, Direct-to-Consumer, DTC, Class II, Exempt, 23andMe, Genetic Testing

FDA Revises Priority ANDA Draft Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).

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

Tags: Priority ANDAs, GDUFA II, Pre-Submission Facility Correspondence, PFC

FDA Describes New GDUFA II User Fee Structure By Michael Mezher - Published 27 October 2017

The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Submission and registration

Tags: User Fees, GDUFA II

Breakthrough Devices: FDA Issues Draft Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance detailing the agency's new program for breakthrough medical devices created by the 21st Century Cures Act.

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

Tags: Breakthrough Devices Program, Priority Review

When to Submit a New 510(k): FDA Finalizes Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Submission and registration

Tags: 510(k), 510(k) change guidance

Health Canada Seeks to Update User Fees for Drug and Device Firms By Zachary Brennan - Published 13 October 2017

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Submission and registration, Veterinary products

Tags: pharmaceutical fees, medical device fees, Health Canada fees

PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: PDUFA VI, prescription drug user fees, draft guidance

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision By Zachary Brennan - Published 06 October 2017

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

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

Tags: GDUFA II, ANDA status updates

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

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

Tags: eCTD, common technical document, ICH guidance

Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

CLIA Waiver Decisions: FDA Begins Posting Summaries By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: CLIA, CLIA Waiver by Application

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

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

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo

Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

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

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

FDA Targets Complex Generic Drugs With New Draft Guidance By Zachary Brennan - Published 02 October 2017

The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

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

Tags: generic drugs, complex generic drugs, FDA draft guidance

FDA Finalizes Guidance on Emerging Manufacturing Tech Program By Michael Mezher - Published 28 September 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing.

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

Tags: Emerging Technology, Continuous Manufacturing, Guidance