Search Results for 21st Century Cures

Showing 1 – 25  of 38

FDA Unveils List of Reusable Devices Requiring New Validation Data By Zachary Brennan - Published 08 June 2017

Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in premarket notification submissions. 

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

Tags: reprocessed medical devices, reusable devices, 21st Century Cures, 510(k)

Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse By Zachary Brennan - Published 16 May 2017

Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse."

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

Tags: Scott Gottlieb, FDA commissioner, opioids, 21st Century Cures

Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation By Zachary Brennan - Published 16 May 2017

Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: 21st Century Cures Act, HHS budget, Trump budget cuts, OMB

FDA Officials Discuss Modernizing the Regulation of Combo Products By Zachary Brennan - Published 15 May 2017

As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: combination product regulation, combo products and FDA, 21st Century Cures

BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices By Zachary Brennan - Published 15 May 2017

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.

Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act

FDA Science Board Weighs Plan for 'Cures' Funds By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act.

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

Tags: FDA science board, Celgene, GSK, Amgen, 21st Century Cures

FDA Proposal Explains Uses for New Innovation Funds By Zachary Brennan - Published 05 May 2017

Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) over the next eight years will have access to more than $500 million in new funds for a variety of new drug, device and clinical trial work.

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

Tags: 21st Century Cures, FDA innovation, FDA innovation funds, DDTs

Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products By Robert D. Cumming, Nancy W. Mathewson, Esq - Published 14 April 2017

This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

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

Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA

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 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

Law Firm Challenges FDA on Combination Product Appeals By Michael Mezher - Published 09 March 2017

Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Citizen Petition, Request for Designation, 21st Century Cures Act

21st Century Cures Act Deadlines Approach in March and June By Zachary Brennan - Published 22 February 2017

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

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

Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA

21st Century Cures: Shifting the Balance of Negotiating Power By Zachary Brennan - Published 25 January 2017

The new 21st Century Cures law has proven to be divisive, with both advocates and critics getting hyperbolic on the law’s potential impact on the drug and medical device industries, as well as on the US Food and Drug Administration (FDA).

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

Tags: 21st Century Cures, pharmaceutical law

'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 By Michael Mezher - Published 15 December 2016

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: CDER 2017 Priorities, 21st Century Cures, PDUFA, GDUFA, BsUFA, Janet Woodcock

FDA, NIH Unveil Initial Framework for Biomarker Qualification By Zachary Brennan - Published 12 December 2016

Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for the proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs.

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

Tags: biomarker, biomarker qualification, 21st Century Cures, Woodcock, evidentiary criteria

FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’ By Zachary Brennan - Published 08 December 2016

Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible."

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: 21st Century Cures, real-world evidence, real-world data and pharmaceuticals

Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns By Zachary Brennan - Published 07 December 2016

The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill.

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

Tags: Cures, 21st Century Cures, regenerative medicine, FDA, safety and efficacy

Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage By Zachary Brennan - Published 06 December 2016

Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition.

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

Tags: 21st Century Cures, GPhA, Leahy, generic drugs, NIH

House to Pass Revamped 21st Century Cures Bill By Zachary Brennan - Published 30 November 2016

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.

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

Tags: 21st Century Cures, #CuresNow, Cancer Moonshot, FDA legislation, lame duck session

Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now

A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH By Zachary Brennan - Published 31 October 2016

With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes.

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

Tags: Cures, 21st Century Cures, Cures bill, biomedical innovation bill, NIH funding

Senate Pushes Work on ‘Cures’ Legislation Back to September By Zachary Brennan - Published 12 July 2016

The Senate’s version of the House-passed 21st Century Cures Act will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices

Tags: Cures, 21st Century Cures, Alexander, NIH funding

Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards By Zachary Brennan - Published 24 May 2016

Ten groups, including the US Pharmacopeial Convention (USP) and Biosimilars Council, are taking major issue with a provision in a seemingly innocuous bill to boost the workforces of the US Food and Drug Administration (FDA) and National Institutes of Health (NIH).

Categories: News, US, FDA, Biologics and biotechnology, Quality, Regulatory strategy

Tags: USP, ASHP, AMCP, APA, NCPA, 21st Century Cures, FDA workforce

Senate Committee Advances Five More Bills as Part of Medical Innovation Package By Zachary Brennan - Published 06 April 2016

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Combination products, Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Packaging, Postmarket surveillance, Product withdrawl and retirement, Reimbursement

Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP

Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act By Michael Mezher - Published 08 December 2015

Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Regulatory strategy, Research and development

Tags: 21st Century Cures, Orphan Product Extensions Now Act, OPEN Act, Pediatric Research Equity Act, PREA, Public Citizen