Search Results for Zachary Brennan

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EMA Headquarters to Move to Amsterdam By Zachary Brennan - Published 20 November 2017

The European Council on Monday voted to move the European Medicines Agency’s (EMA) headquarters and nearly 900 staffers from London to Amsterdam – a move that’s expected to begin tomorrow and finish 30 March 2019.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EMA relocation, EMA move, EMA headquarters, Milan EMA

House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations By Zachary Brennan - Published 17 November 2017

The Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis.

Categories: News, US, FDA, Crisis management, Regulatory strategy, Submission and registration

Tags: NDAA, emergency use authorization

FDA Begins Adding Suffixes to Newly Approved Biologics' Names By Zachary Brennan - Published 17 November 2017

The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in its previous policy of only adding the suffixes to biosimilars.

Tags: nonproprietary name, FDA biologics naming, naming policy for medicines

FDA Unveils New Regenerative Medicine Framework By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regenerative medicine, RMAT, FDA guidance

Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included By Zachary Brennan - Published 16 November 2017

The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it.

Categories: News, US, FDA, Clinical, Reimbursement, Research and development

Tags: orphan drug tax credit, tax reform

FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday finalized guidance first released in 2015 to clarify when direct marking of devices with a unique device identifier (UDI) is required.

Categories: News, US, FDA, Medical Devices

Tags: unique device identifiers

Drug Labels: Experts Note Importance of Faster Updates By Zachary Brennan - Published 15 November 2017

The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday.

Categories: News, US, FDA, Drugs, Government affairs, Labeling

Tags: drug labels, cancer drug labels, Friends of Cancer Research

FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches By Zachary Brennan - Published 14 November 2017

Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees.

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

Tags: Pazdur, Marks, Woodcock, oncology center of excellence

MDR, IVDR: Competent Authorities Lay Out Road Map By Zachary Brennan - Published 13 November 2017

The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, CAMD

Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate By Zachary Brennan - Published 13 November 2017

New research published last week digs into cross-national regulatory divergences, with a focus on why some US labels for certain flu treatments say the medicines have not been proven to reduce complications while EU labels claim the opposite.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs

Tags: Relenza, Tamiflu, regulatory divergence

Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary By Zachary Brennan - Published 13 November 2017

President Donald Trump on Monday morning announced via Twitter his intention to nominate Alex Azar, former senior vice president at Eli Lilly and deputy HHS secretary under President George W. Bush, to be the next HHS secretary.

Categories: News, US, Drugs, Reimbursement

Tags: Azar, HHS Secretary, Eli Lilly

Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit By Zachary Brennan - Published 10 November 2017

The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead.

Categories: News, US, Clinical, Research and development

Tags: GOP tax plan, Senate tax reform, Hatch, orphan drug tax credit

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA By Zachary Brennan - Published 10 November 2017

The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Medical Devices

Tags: Department of Defense, emergency use authorization

EMA Offers Support for More Research on DIVI Biomarkers By Zachary Brennan - Published 09 November 2017

European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development.

Categories: News, Europe, US, EMA, FDA, Clinical, Government affairs, Research and development

Tags: Guido Rasi, DIVI biomarkers

FDA Expands Generic Drug Priority Reviews By Zachary Brennan - Published 09 November 2017

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug review, generic drug approval, GDUFA

Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications By Zachary Brennan - Published 08 November 2017

Back in May, the US Food and Drug Administration (FDA) denied a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet), resulting in lawsuit filed by the drugmaker. A JAMA viewpoint published Wednesday argues that a decision in Amgen's favor could end up diminishing FDA's ability to encourage clinically meaningful pediatric studies.

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

Tags: Amgen, Sensipar, pediatric exclusivity, written requests

Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline By Zachary Brennan - Published 08 November 2017

European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence

Tags: notified bodies, Team-NB, MDR, IVDR

FDA Warns Chinese Firm for Confusing API in OTC Drug By Zachary Brennan - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs made the firm was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate.

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

Tags: hydrocortisone, China API manufacturing, FDA warning letter

Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say By Zachary Brennan - Published 07 November 2017

Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy.

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

Tags: DNA sequencing, Oncology Center of Excellence, biomarker, OS

Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint By Zachary Brennan - Published 07 November 2017

Journal editors should encourage research authors to disclose the role of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in clinical trial design and execution, Aaron Kaplan of the Heart & Vascular Center at Dartmouth-Hitchcock Medical Center and Ariel Stern of Harvard Business School, wrote in a JAMA viewpoint.

Categories: News, US, CDRH, Government affairs, Medical Devices

Tags: medical device clinical trials,

FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included By Zachary Brennan - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

Categories: News, US, FDA, Over the counter drugs, Labeling

Tags: aspirin, FDA label, cardiovascular images

CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect By Zachary Brennan - Published 06 November 2017

The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term.

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

Tags: biosimilars, Medicare Part B, biosimilar reimbursement

Needle Destruction Devices: FDA Proposes Reclassification By Zachary Brennan - Published 06 November 2017

The Food and Drug Administration (FDA) on Monday proposed reclassifying the needle destruction device, renamed as "sharps needle destruction device," from a Class III device into Class II (special controls), subject to premarket notification.

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

Tags: needle destruction device, sharps needle destruction

Gottlieb Discusses Efficiencies, Opioids, Pricing and More at National Press Club By Zachary Brennan - Published 03 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took questions at the National Press Club in Washington, D.C. on Friday, offering perspective on what the agency is doing to be more efficient, actions related to the opioid epidemic and how FDA plays a role in the drug pricing debate.

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

Tags: National Press Club, Scott Gottlieb, opioids, drug prices