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Filtering on: "topics regulatory strategy"

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Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients By Michael Mezher - Published 23 March 2017

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

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

Tags: Delayed Graft Function, DGF, Draft Guidance

FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants By Zachary Brennan - Published 21 March 2017

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: News, US, FDA, TGA, WHO, Compliance, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: breast implants, lymphoma, BIA-ALCL

Maryland House Passes Bill on Price Gouging of Generic Drugs By Zachary Brennan - Published 21 March 2017

Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: price gouging, pharmaceutical price legislation, Maryland drug price gouging

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

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

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, CRLs, biosimilars

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Class II devices, 21st Century Cures, FD&C Act

AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017 By Zachary Brennan - Published 09 March 2017

Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: AdvaMed, device guidance, FDA guidance 2017

EU Industry Groups Urge Caution on Biosimilar Switching By Zachary Brennan - Published 09 March 2017

Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday.

Categories: Europe, EC, EMA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar switching, regulatory requirements biosimilars

505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times By Zachary Brennan - Published 09 March 2017

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development.

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

Tags: 505(b)(2) pathway, new drug approvals, Tufts, approval times

Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March By Gloria Hall - Published 08 March 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.

Categories: Features, CFDA, EMA, FDA, Health Canada, ISO, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Focus, Feature Articles, Feature Summary

Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017) By Nick Paul Taylor - Published 07 March 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, TGA inspections, NPPA

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

GAO: Drugmakers Want More Clarity on Antibiotic Incentives By Michael Mezher - Published 03 March 2017

Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO).

Categories: News, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: Government Accountability Office, GAO, Generating Antibiotic Incentives Now, GAIN Act, Qualified Infectious Disease Product, QIDP

FDA’s Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations By Zachary Brennan - Published 02 March 2017

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass reauthorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, BsUFA, Woodcock, FDA user fees

US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections By Zachary Brennan - Published 02 March 2017

After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

Categories: News, Europe, US, EC, EMA, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, EMA and FDA initiatives, mutual recognition agreements, US-EU international agreement

International Generic Drug Regulators Unveil New Biowaiver Assessment Template By Zachary Brennan - Published 01 March 2017

Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members.

Categories: News, Asia, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, WHO, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: IGDRP, biowaivers, Biopharmaceutics Classification System

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape By Patricia Hurley, PhD, Sarah Jurmeister, PhD, Kathryn Parsley, PhD - Published 28 February 2017

This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Advanced Therapies, ATMP

Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal By Zachary Brennan - Published 22 February 2017

A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions.

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

Tags: mutual GMP recognition, TTIP, EU-US trade deals

Sarepta Sells Priority Review Voucher for $125M to Gilead By Zachary Brennan - Published 21 February 2017

Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

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

Tags: Sarepta, Gilead, priority review voucher, PRV, Cures

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

House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal By Zachary Brennan - Published 16 February 2017

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

Categories: US, FDA, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: DeLauro, mandatory drug recall, FDA authority, drug recalls, homeopathic