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Filtering on: "topics clinical"

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FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

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

Tags: Expanded Access, Compassionate Use, Right-to-Try

Real World Evidence: FDA Commits to Advancing its Use By Zachary Brennan - Published 19 September 2017

To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

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

Tags: real world evidence, Scott Gottlieb, clinical data

FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

Categories: News, US, CDRH, Clinical, Medical Devices

Tags: organ preservation, FDA draft guidance

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials

CDRH Finalizes Guidance on Reporting Age, Race and Ethnicity Data in Studies Published 12 September 2017

The final guidance outlines FDA’s recommendations and expectations for patient enrollment, data analysis, and reporting of age, race and ethnicity data in medical device clinical studies.

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

Tags: medical devices, final FDA guidance

FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Crisis management, Drugs

Tags: Keytruda, Merck, multiple myeloma, FDA alert

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

Early Feasibility Studies for Devices: FDA Highlights Success From Pilot By Michael Mezher - Published 30 August 2017

In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms.

Categories: News, US, CDRH, Clinical, Medical Devices, Submission and registration

Tags: Early Feasibility Study, EFS, EFS Program, Angel Catheter

European Regulatory Roundup: UK Calls for Brexit to Have Little Impact on Regulation (24 August 2017) By Nick Paul Taylor - Published 24 August 2017

The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal they will need persuade European negotiators to revise their position.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

Patients Not Always Informed of Study's Purpose in Noninferiority Trials By Michael Mezher - Published 23 August 2017

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

Categories: News, EMA, FDA, Clinical, Drugs, Ethics

Tags: Noninferiority, Superiority, Antibiotics, Clinical Trials, Informed Consent

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

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

Tags: PREA, FDASIA, non-compliance letters FDA

Protalex Wins $403K Grant from FDA Office of Orphan Products Development By Zachary Brennan - Published 18 August 2017

Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).

Categories: News, US, FDA, Clinical, Drugs, Orphan products

Tags: OOPD, orphan drug, Protalex

ICH Details Pilot Training Programs for 2017 By Michael Mezher - Published 16 August 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: News, Japan, Europe, US, ICH, Clinical, Drugs, Manufacturing, Submission and registration

Tags: ICH, Training, eCTD, GMP, GCP

Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials By Michael Mezher - Published 04 August 2017

In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making.

Categories: News, Biologics and biotechnology, Clinical, Drugs

Tags: Randomized Controlled Trials, RCTs, Observational Studies

European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017) By Nick Paul Taylor - Published 03 August 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: European regulatory roundup, drugs for older people, radiopharmaceuticals

European Regulatory Roundup: EMA Adopts Revised First-in-Human Trial Guidance; UK Appoints Industry Veteran Ahead of Negotiations with Pharma (27 July 2017) By Nick Paul Taylor - Published 27 July 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Blood, Clinical, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup

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

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

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

Tags: Informed Consent, Minimal Risk, 21st Century Cures

Report Calls on FDA to Adopt New Standard for Reviewing Opioids By Michael Mezher - Published 14 July 2017

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: News, US, FDA, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Opioids, Opioid Epidemic

FDA Officials: Master Protocols Needed for Precision Medicine By Michael Mezher - Published 07 July 2017

In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple drugs or multiple diseases (or both) simultaneously are needed to efficiently generate evidence for precision medicines.

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

Tags: Master Protocols

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments By Zachary Brennan - Published 03 July 2017

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder.

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

Tags: EMA and FDA, Gaucher disease, rare pediatric disease

Is FDA Too Slow? Researchers Debunk Claims By Michael Mezher - Published 03 July 2017

Despite being consistently ranked among the world's fastest regulators, the US Food and Drug Administration (FDA) is often criticized for being slow and bureaucratic.

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

New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? By Zachary Brennan - Published 28 June 2017

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Human cell and tissue

Tags: Texas stem cell treatments, stem cells