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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

CBER Director Offers a Peek Into the Complexities of Where the Center is Headed By Zachary Brennan - Published 20 June 2017

In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines.

Categories: News, US, CBER, Biologics and biotechnology

Tags: CBER, CAR-T, hemophilia, Peter Marks

CBER Director Focuses on Flexibility to Advance Regenerative Medicines By Michael Mezher - Published 08 May 2017

Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday said his office is equipped to support the development of cutting edge treatments, such as cell and gene therapies.

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

Tags: Regenerative Medicine, Cell and Gene Therapy, Advanced Therapies, RMAT Designation

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

Humacyte Receives First of FDA’s Regenerative Medicine Designations By Zachary Brennan - Published 20 March 2017

The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: RMAT designation, regenerative medicine, 21st Century Cures

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

FDA Begins Accepting Regenerative Therapy Applications for RAT Designation By Zachary Brennan - Published 20 January 2017

The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act making drugs eligible for designation as a regenerative advanced therapy (RAT).

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

Tags: RAT designation, regenerative therapy, cell therapy, OTAT

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

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

FDA Calls Out Unproven Claims of Unapproved Blood Device By Zachary Brennan - Published 28 November 2016

Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels.

Categories: News, US, CBER, Advertising and Promotion, Labeling, Medical Devices, Quality

Tags: Dr. PRP America, blood plasma levels, PRP Kit, centrifuge

FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies By Zachary Brennan - Published 21 November 2016

The US Food and Drug Administration’s (FDA) Office of Compliance in Biologics Quality in the Center for Biologics Evaluation and Research (CBER) on Monday released an untitled letter sent to Cambridge, MA-based Antera Therapeutics because it's selling an unapproved biologic intended to prevent a peanut allergy.

Categories: News, US, CBER, Biologics and biotechnology, Crisis management, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: peanut allergy, allergenic, FDA warning, untitled letter, Antera, Aralyte

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

FDA’s CBER Restructures and Creates New Office of Tissues and Advanced Therapies By Zachary Brennan - Published 19 October 2016

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday announced that it will restructure after an internal review and create a new Office of Tissues and Advanced Therapies (OTAT), which was formerly known as the Office of Cellular, Tissue and Gene Therapies (OCTGT).

Categories: News, US, CBER, Biologics and biotechnology, Government affairs

Tags: CBER, OTAT, OBRR, OVRR, OCTGT

CBER Strategic Plan 2017-2019: Increase Threat Preparedness, Improve International Collaborations By Zachary Brennan - Published 17 October 2016

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released an interim strategic plan for FY 2017 through 2019, offering the same six overarching goals the center initially developed in 2011, though with updated strategies to achieve them.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: CBER strategic plan, pandemic preparedness, FDA and international partners

Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance By Zachary Brennan - Published 16 September 2016

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research this week issued final guidance for investigation new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early-phase clinical trials.

Categories: News, US, CBER, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: gene therapies, FDA guidance, IND guidance

FDA Sends Untitled Letter to Danish Drugmaker Over GMP Issues By Michael Mezher - Published 25 July 2016

The US Food and Drug Administration (FDA) has issued an untitled letter to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility.

Categories: News, Europe, US, CBER, Biologics and biotechnology, Manufacturing, Quality

Tags: ALK-Abelló, Untitled Letter, Pharmalgen

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

Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions By Zachary Brennan - Published 20 June 2016

Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Government affairs, Quality, Research and development

Tags: biosimilars, interchangeability, BPCIA

FDA’s CBER to Forge Stronger Ties With WHO By Zachary Brennan - Published 01 June 2016

The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards.

Categories: News, US, CBER, Biologics and biotechnology, Due Diligence, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: vaccine prequalification, FDA and WHO, regulatory oversight, drug regulatory standards

Pharma Companies: FDA Wants New Info for FY2017 User Fees By Michael Mezher - Published 23 May 2016

The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: PDUFA, PDUFA V, User fees

70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names By Zachary Brennan - Published 12 May 2016

The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilar names, Zarxio, meaningful suffixes for biosimilars, FDA guidance

CBER Unveils New Electronic Reporting System for Vaccine Adverse Events By Zachary Brennan - Published 28 April 2016

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines.

Categories: News, US, CBER, Biologics and biotechnology, Crisis management, Ethics, Government affairs, Postmarket surveillance

Tags: vaccine adverse events, vaccine reporting, electronic reporting of adverse events

FDA Looking for Two New Cellular and Gene Therapy Fellows Published 28 March 2016

The US Food and Drug Administration’s Division of Cellular and Gene Therapies is opening up two contract fellowship positions: one to study the potential of human pluripotent stem cells for developing gene and cell therapies, and one to further investigate mechanisms that RNA viruses use to inhibit host immune cell function.

Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: FDA fellowships, gene and cell therapy, cell function, RNA viruses

FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs By Michael Mezher - Published 16 March 2016

The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.

Categories: News, CBER, Biologics and biotechnology, Clinical, Manufacturing, Research and development

Tags: CAR T-cells, chimeric antigen receptors, CD19, Recombinant DNA Advisory Committee, Cancer, Oncology, Juno, Kite, Novartis, B-cell lymphoma, Investigational new drug application, IND