Search Results for

Filtering on: "topics clinical"

Showing 1 – 25  of 452

21st Century Cures Act Deadlines Approach in March and June By Zachary Brennan - Published 22 February 2017

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

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

Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA

EMA Outlines GCP Inspection Plan for 2017 By Zachary Brennan - Published 21 February 2017

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GCP guidelines, GCP inspections, trial site inspections

Transparency Push: EMA to Revise Policy on Document Access By Zachary Brennan - Published 17 February 2017

The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, Government affairs

Tags: pharmaceutical data transparency, EMA transparency

CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics By Michael Mezher - Published 16 February 2017

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: News, EMA, FDA, Clinical, Drugs

Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Post-Authorisation Studies, PAS, EU PAS Register

EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs By Zachary Brennan - Published 13 February 2017

The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Clinical, Drugs

Tags: PDCO, EMA committee, ICH Q&A, S9

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

MHRA Looks to Increase Medical Device Fees By Michael Mezher - Published 06 February 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies.

Categories: News, Europe, EC, MHRA, Clinical, In vitro diagnostics, Medical Devices

Tags: Fees, Notified Bodies

Trump Signals Support for 'Right-to-Try' Movement By Michael Mezher - Published 02 February 2017

In a meeting with pharmaceutical industry executives on Tuesday, President Donald Trump expressed his concern that the US Food and Drug Administration (FDA) is standing in the way of terminally ill patients accessing unapproved drugs as treatments of last resort.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Government affairs

Tags: Trump, Right-to-Try

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

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success By Michael Mezher - Published 26 January 2017

France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation.

Categories: News, Europe, Clinical

Tags: ANSM, Clinical Trials Regulation

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

Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) By Nick Paul Taylor - Published 24 January 2017

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, clinical trial guidance, import licenses, advisory committees

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report By Zachary Brennan - Published 19 January 2017

With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials.

Categories: News, US, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Phase II trials, Phase III trials, pharmaceutical development, R&D

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

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

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

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

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

FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs By Michael Mezher - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: Investigational Device Exemption, Final Guidance

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs By Michael Mezher - Published 11 January 2017

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: National Cancer Institute, NCI, NCI Formulary, Oncology