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FDA Opens for Comment Revised ICH Guideline on Statistical Principles for Clinical Trials By Zachary Brennan - Published 30 October 2017

The US Food and Drug Administration (FDA) on Monday opened for comment a newly revised International Council for Harmonisation (ICH) guideline intended to better align the choice of statistical methods with questions of regulatory importance, and to improve the reliability of decisions about and representations of the effects of medical products.

Categories: News, US, FDA, ICH, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: statistical principles for clinical trials, E9(R1), ICH guidelines

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing By Zachary Brennan - Published 03 October 2017

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Right-to-try, E&C Committee, Gottlieb, GAO, expanded access

ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation By Michael Mezher - Published 29 September 2017

The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June.

Categories: News, ICH, Biologics and biotechnology, Clinical, Drugs, Quality

Tags: ICH Assembly, Montreal, E8(R1), Pediatric Extrapolation

Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations By Michael Mezher - Published 18 September 2017

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors.

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

Tags: Quantitative Benefit-Risk Assessment, ICH M4E(R2)

EMA Opens Consultations of Two Revised ICH Guidelines By Zachary Brennan - Published 31 August 2017

The European Medicines Agency (EMA) on Thursday released for consultation a revised ICH guideline on reproductive toxicology and an addendum to another guideline on statistical principles for clinical trials.

Categories: News, Canada, Europe, US, EMA, ICH, Clinical, Drugs

Tags: ICH E9, ICH S5

ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data By Michael Mezher - Published 26 July 2017

The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection.

Categories: News, FDA, ICH, Clinical, Drugs

Tags: Safety Data, ICH, International Conference for Harmonization, E19

FDA Updates on Two ICH Guidelines By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents.

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

Tags: M4E(R2), Benefit-Risk Assessment, Efficacy, Q3C, Residual Solvents

European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017) By Nick Paul Taylor - Published 29 June 2017

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

Categories: EC, EMA, MHRA, Drugs, Government affairs

Tags: Swiss drug ordinances, ICH E2E, CVMP

House Subcommittee Advances User Fee Reauthorizations By Zachary Brennan - Published 18 May 2017

Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: E&C, FDA user fees, user fee reauthorization

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, China heparin, House E&C, FDA investigations

New House E&C Chairman to Consider Value-Based Drug Price Negotiations By Zachary Brennan - Published 02 February 2017

The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices.

Categories: News, US, Drugs, Reimbursement

Tags: Walden, House E&C, Schrader, Merck, CMS drug negotiations

Swissmedic To Prioritize Electronic Adverse Events Reports By Michael Mezher - Published 30 January 2017

Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports.

Categories: News, Europe, Drugs, Postmarket surveillance

Tags: Swissmedic, Adverse Drug Reaction, ADR, ELViS, E2B Gateway

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

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 Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance By Michael Mezher - Published 21 November 2016

The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials.

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

Tags: Pediatric drug development, ICH E11

FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics By Zachary Brennan - Published 22 June 2016

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: ISCRs, ICH, eCTD, E2B(R3)

ICH Genomic Sampling Guidance: FDA Begins Consultation By Michael Mezher - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling.

Categories: News, US, EC, FDA, Health Canada, ICH, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs

Tags: ICH, International Conference for Harmonization, E18, Genomic Sampling

FDA Defends Plans to Regulate LDTs at House Hearing By Michael Mezher - Published 17 November 2015

The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs).

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Laboratory developed tests, LDTs, House Energy and Commerce Committee, E&C

Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill By Alexander Gaffney, RAC - Published 13 May 2015

An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Orphan products

Tags: Congress, 21st Century Cures Initiative, 21st Century Cures Act, Legislation, Bill, Energy and Commerce Committee, E&C

Legislators to Obama: Help us in Effort to Reform FDA Regulation By Alexander Gaffney, RAC - Published 20 January 2015

For months, legislators on the House Energy and Commerce (E&C) Committee have been working with a large group of stakeholders in the hopes of developing a series of reforms to the way the US Food and Drug Administration (FDA) approves new drugs and medical devices.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: E&C, Barack Obama, Energy and Commerce Committee, Congress, Legislation, 21st Century Cures

How Should Diagnostic Tests be Regulated? Congress Wants to Know By Alexander Gaffney, RAC - Published 12 December 2014

A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics.

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

Tags: LDT, Lab Developed Tests, Laboratory Developed Tests, Congress, Energy and Commerce Committee, E&C, Whitepaper, White Paper

FDA Grapples With Lesser-Known Costs of Clinical Trials Transparency By Alexander Gaffney, RAC - Published 14 July 2014

US medical device regulators soon plan to hold a public hearing to discuss how the results of cardiovascular outcomes trials (CVOTs) can be kept confidential until they are completed.

Categories: News, US, CDER, Clinical, Postmarket surveillance

Tags: CVOT, Cardiovascular Outcomes Trials, Clinical Trials Transparency, DMC, ICH E9, Interim Results

FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities By Alexander Gaffney, RAC - Published 28 May 2014

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines.

Categories: News, US, CBER, ICH, Biologics and biotechnology, Postmarket surveillance

Tags: US, FDA, CBER, Vaccine, VAERS, ICSR, Adverse Event, E2B (R3), ICH, Pilot Program

ICH Looks to Clarify 'Key Issues' With E2C Adverse Event Reporting Guideline By Alexander Gaffney, RAC - Published 14 April 2014

Categories: ICH

Tags: PAER, DSUR, E2C (R2), E2C, PSUR, PBRER, Q&A, Latest News