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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

FDA Releases Annual Report on Biological Product Deviations By Michael Mezher - Published 28 June 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers.

Categories: News, US, CBER, Biologics and biotechnology, Blood, Human cell and tissue

Tags: Deviations, CBER

FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials By Michael Mezher - Published 15 February 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.

Categories: News, US, CBER, Advertising and Promotion, Blood, Compliance, Drugs

Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials

Challenges Surrounding the Development and Manufacturing of ATMPs Continue By Zachary Brennan - Published 03 February 2017

The experience of conducting clinical trials with advanced therapy medicinal products (ATMPs) in a real-world clinical setting, according to a new European Medicines Agency (EMA) summary of a conference discussion, can mean “battling multiple and often ridiculous barriers.”

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Blood, Combination products, Manufacturing

Tags: ATMPs, EMA conferences

FDA To Disclose Unredacted Advisory Committee Members' CVs By Zachary Brennan - Published 03 February 2017

In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members.

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

Tags: FDA advisory committees, conflict of interest

Update: CBER Announces Planned Guidance for 2017 By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research on Wednesday announced the guidance documents it plans to publish in 2017.

Categories: News, US, CBER, Biologics and biotechnology, Blood

Tags: Guidance

FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission By Michael Mezher - Published 18 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT).

Categories: News, US, FDA, Biologics and biotechnology, Blood, Human cell and tissue

Tags: Nucleic acid testing, NAT, Hepatitis B, HBV

FDA to Reevaluate Gay Blood Donor Guidance By Michael Mezher - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday called for public input on its December 2015 guidance that ended the agency's indefinite ban on gay men donating blood in favor of a 12-month deferral since the donor last had sex with another man.

Categories: News, US, FDA, Blood

Faulty Filter Prompts Recall of Leukocyte Reduction Device By Michael Mezher - Published 23 June 2016

The US Food and Drug Administration (FDA) on Thursday warned healthcare providers that a faulty filter in recently distributed lots of Haemonetics' Leukotrap RC System can result in higher than acceptable leukocyte counts in blood used in transfusions.

Categories: News, US, CBER, Blood, Product withdrawl and retirement

Tags: Haemonetics, Leukotrap

Advanced Therapies: Stakeholders Call for EMA Changes on Regulations, Manufacturing By Zachary Brennan - Published 03 June 2016

The European Medicines Agency (EMA) on Friday released a report outlining the concerns and regulatory changes described by developers, manufacturers and investors in advanced therapy medicinal products (ATMPs), which include gene therapies, tissue-engineered products and somatic cell therapies, at a meeting last week.

Categories: News, Europe, EC, Biologics and biotechnology, Blood, Clinical, Combination products, Crisis management, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: ATMPs, gene therapy manufacturing, cell therapy, advanced therapies

FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator By Zachary Brennan - Published 07 April 2016

Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments.

Categories: News, US, FDA, Blood, Clinical, Combination products, Crisis management, Drugs, Due Diligence, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: expanded access, Right to Try, compassionate use, Reagan-Udall Foundation

FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika By Michael Mezher - Published 30 March 2016

The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus.

Categories: News, FDA, Blood, In vitro diagnostics

Tags: Zika virus, Roche Diagnostics

CBER Calls on HCT/P Manufacturers to Report Adverse Events Within 15 Days By Zachary Brennan - Published 08 March 2016

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases.

Categories: News, US, CBER, Biologics and biotechnology, Blood, Crisis management, Human cell and tissue, Postmarket surveillance

Tags: HCT/Ps, adverse event reporting, vascular graft, amniotic membrane

Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks By Michael Mezher - Published 16 February 2016

The US Food and Drug Administration (FDA) is recommending blood banks defer donations from recent travelers to Zika-affected countries.

Categories: News, Latin America and Caribbean, US, FDA, Blood

Tags: Zika, Blood donor screening

FDA Ends Indefinite Ban on Gay, Bisexual Blood Donors By Michael Mezher - Published 21 December 2015

The US Food and Drug Administration (FDA) finalized guidance Monday that would end the agency's policy of indefinitely deferring gay and bisexual men, or men who have sex with men (MSM), from donating blood.

Categories: News, US, CBER, Blood, Government affairs

FDA Authorizes First Human Study to Use In Vivo Genome Editing Application By Zachary Brennan - Published 08 December 2015

The US Food and Drug Administration (FDA) broke new ground last week when it authorized the world’s first human clinical trial for an in vivo genome editing application.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Drugs, Government affairs, Human cell and tissue, Manufacturing, Preclinical, Quality, Research and development

Tags: gene therapies, Sangamo, clinical trials for gene therapies, in vivo genome editing

FDA Offers Guidance for Blood Establishments During Ebola Outbreaks By Michael Mezher - Published 02 December 2015

The US Food and Drug Administration (FDA) has released new recommendations for blood establishments to implement additional screening measures during Ebola virus outbreaks.

Categories: News, Africa, US, CBER, WHO, Biologics and biotechnology, Blood, In vitro diagnostics, Medical Devices, Orphan products

Tags: Ebola

Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches By Zachary Brennan - Published 25 November 2015

As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for preclinical testing programs for these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Business Skills, Due Diligence, Human cell and tissue, Preclinical, Quality, Regulatory strategy

Tags: cancer gene therapies, CBER, FDA regulations on gene therapy, regulatory issues for CBER

UK Agencies Look to Overhaul Cancer Drugs Fund By Zachary Brennan - Published 19 November 2015

The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Blood, Crisis management, Drugs, Government affairs, Preclinical, Quality, Reimbursement, Research and development

Tags: cancer drugs, biotech, NICE, NHS, UK cancer drugs, EMA

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

FDA Details Theranos Deficiencies in Two Form 483s By Zachary Brennan - Published 27 October 2015

The heavily-redacted Form 483s released by the US Food and Drug Administration (FDA) on Tuesday for the blood testing company Theranos include 14 observations, with several on device design, classification and on how the company deals with complaints.

Categories: News, US, FDA, Blood, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Theranos, Elizabeth Holmes, FDA, Form 483

FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration By Michael Mezher - Published 06 October 2015

The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems.

Categories: News, US, FDA, Blood, Drugs, Regulatory strategy

Tags: REMS, Risk evaluation and mitigation strategies, Structured product label, SPL

Regulatory Recon: FDA Offers New Scope Cleaning Recommendations, Months After UCLA Outbreak (5 August 2015) By Michael Mezher - Published 05 August 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: News, Blood, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products By Michael Mezher - Published 03 June 2015

The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products.

Categories: News, Europe, EMA, Biologics and biotechnology, Blood, Regulatory strategy

Tags: Plasma-derived medicinal products, Plasma Master File, PMF

HHS Establishes Organ Donation Policy for Patients With HIV By Alexander Gaffney, RAC - Published 08 May 2015

The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV).

Categories: News, US, Blood, Compliance, Ethics

Tags: HIV, Organ Donation, HOPE Act, HIV Organ Policy Equity Act, National Organ Transplant Act, NOTA