Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Joanne Hawana ordered by Published Date Descending.
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Update On FDA's Comprehensive Regenerative Medicine Policies And Enforcement Activities
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the "grace period" the Agency has extended for certain regenerative medicine product developers to
United States
15 May 2019
Some BPCIA Clouds Begin To Clear: FDA Issues Final Plans For March 2020 "Deemed To Be A License" Provision
In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market.
United States
2 Jan 2019
FDA Releases Series Of Gene Therapy Guidance Documents: From Drug Development To Postmarket Monitoring
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development...
United States
16 Jul 2018
Biosimilars In The Limelight – A Lot Has Happened Since January 2018
A lot has happened since we last addressed new biosimilar developments in January 2018.
United States
25 Jun 2018
NDA/ANDA Holders Must Affirmatively Submit Data To FDA Or Risk Losing Products' Active Listing In The Orange Book
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
United States
19 Jan 2018
Biosimilar Market Developments Continue Apace In 2018
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products
United States
19 Jan 2018
FDA 2017 Year In Review: Therapeutic Products, Part 2
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA's actions for 2017 in the therapeutic products space.
United States
21 Dec 2017
FDA User Fee Hearings Picking Up Steam On Capitol Hill
As we noted previously in our introductory blog post on the 2017 User Fee Act reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017...
United States
5 Apr 2017
President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway For Regenerative Medicine
The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises.
United States
21 Dec 2016
Administration's Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy
After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.
United States
26 Sep 2016
FDA Convenes Two-Day Public Hearing On Human Cell And Tissue Product Regulatory Paradigm
Earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.
United States
20 Sep 2016
FDA Approves Third Biosimilar Product
As we predicted in yesterday's post, FDA approved a new biosimilar product, Sandoz's Erelzi (etanercept-szzs), which is a biosimilar to Amgen's Enbrel (etanercept), on August 30th.
United States
6 Sep 2016
Biosimilar FDA Approvals On The Horizon As More States Enact Substitution Laws
Shortly after we published this blog post, FDA approved Sandoz's biosimilar to Amgen's Enbrel (etanercept), called Erelzi (etanercept-szzs).
United States
5 Sep 2016
FDA Comes Through On Promise To Release NGS Device Draft Guidelines Expeditiously
The Agency's stated goal is "to create a flexible and adaptive regulatory approach to the oversight of NGS-based tests," given the rapid and innovative advancements being made in the technologies.
United States
13 Jul 2016
FDA Releases Draft Guidance For 3D Printed Medical Devices
On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing.
United States
24 May 2016
Agencies Engaged In Federal Biotech Overhaul To Host Final Two Public Sessions In March
After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology ...
United States
7 Mar 2016
Laboratories – 2015 Year In Review (Video Content)
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come.
United States
31 Dec 2015
FDA Commits To Moving Forward With LDT Regulation
FDA's draft guidance defines an LDT as a type of in vitro diagnostic (IVD), which is a test that detects a disease, condition, or infection.
United States
25 Nov 2015
FDA Invites Genome Scientists To Come Play In The PrecisionFDA "Sandbox"
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
United States
17 Nov 2015
Genetic Testing, Genome Sequencing, And The FDA
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) to the rapidly developing world of genetic and genomic testing services.
United States
17 Nov 2015
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