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Filtering on: "topics submission and registration"

Showing 1 – 25  of 425

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices By Michael Mezher - Published 13 January 2017

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: News, Europe, US, EC, FDA, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Adverse Event Reports, AER, Safety

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

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

Tags: 180-day exclusivity, generic drugs, FDA guidance

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

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

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

FDA Offers Draft Guidance on New Pre-Request for Designation Process By Michael Mezher - Published 12 January 2017

After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests.

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

Tags: Pre-Request for Designation, Pre-RFD, Combination Products

CBER Director Touts Center's FY2016 Performance By Michael Mezher - Published 06 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: CBER, PDUFA, MDUFA, BLA

IND Application Fast Facts By Valerie Fauvelle - Published 06 January 2017

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Submission and registration

Tags: IND, Investigational New Drug Application

FDA Revises Refuse-to-Receive Guidance for ANDAs By Zachary Brennan - Published 21 December 2016

The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA.

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

Tags: ANDA, refuse-to-receive an ANDA, GDUFA, generic drugs

Complex Medicinal Products - the Other 'Biosimilar' By Douglas W. Balogh, PhD - Published 21 December 2016

This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.

Categories: Features, US, FDA, Generic drugs, Regulatory strategy, Submission and registration

Tags: Non-Biological Complex Drugs, NBCD

International Medical Device Regulatory Update: News and Views From San Jose By Randolph Fillmore - Published 20 December 2016

Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Categories: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump By Michael Mezher - Published 19 December 2016

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

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

Tags: PDUFA VI, User Fees, Trump, BIO

'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 By Michael Mezher - Published 15 December 2016

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

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

Tags: CDER 2017 Priorities, 21st Century Cures, PDUFA, GDUFA, BsUFA, Janet Woodcock

FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices By Zachary Brennan - Published 13 December 2016

The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices, Regulatory intelligence, Submission and registration

Tags: emerging signals, medical device risks, medical device data, FDA publishing medical device data

EMA Revises Clinical Data Publication Guidance, Updates on Program By Michael Mezher - Published 09 December 2016

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

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

Tags: Clinical trial transparency, Clinical study reports

Medical Device Performance Goals: FDA Offers a Quarterly Update By Zachary Brennan - Published 09 December 2016

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

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

Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent

Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes By Zachary Brennan - Published 06 December 2016

Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes.

Categories: News, US, Biologics and biotechnology, Business and Leadership, Drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: pharmaceutical price transparency, drug prices, increases in drug prices, Vermont pharmaceuticals, Medicaid

FDA Classifies Post-Concussion Test By Michael Mezher - Published 05 December 2016

Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.

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

Tags: ImPACT, Concussion, Post-Concusion, Class II, De Novo

ICH Advances Three Guidance Documents By Zachary Brennan - Published 02 December 2016

The International Council for Harmonisation (ICH) earlier this week advanced two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.

Categories: News, Africa, Asia, Canada, Europe, US, FDA, ICH, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Q11, Q3C(R6), E6(R1), ICH guidelines, drug manufacturing

FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses Published 01 December 2016

The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format.

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

Tags: Physiology based pharmacokinetics analyses, PBPK

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

EMA Highlights Central Nervous System Drug Development Challenges By Michael Mezher - Published 29 November 2016

The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia.

Categories: News, Europe, EMA, Clinical, Drugs, Preclinical, Submission and registration

Tags: Central nervous system disorders, CNS

A Summary of 10 Years of Paediatric Legislation in the European Union By Hans van Bronswijk, MD, PhD - Published 28 November 2016

This article summarizes 10 years of experience with paediatric regulations in the EU.

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

Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)

EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs By Zachary Brennan - Published 21 November 2016

The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines.

Categories: News, Europe, EC, EMA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EMA, type II variation, orphan medicines, COMP

EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report By Zachary Brennan - Published 15 November 2016

The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the Pediatric Regulation, ten years after its implementation.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Compliance, Due Diligence, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Paediatric Regulation, PIPs, PIP cost to pharmaceutical industry

Industry Groups Call for Clarity in New 510(k) Device Modifications Guidance By Michael Mezher - Published 14 November 2016

Prominent medical device manufacturers and industry groups are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on submitting a new 510(k) for changes to a medical device.

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

Tags: 510(k) device modifications