Searching Content indexed under Healthcare by Joanne Hawana ordered by Published Date Descending.
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Cannabis-Derived Ingredients In FDA-Regulated Products: More Questions Than Answers At FDA's May 2019 Public Hearing
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing "to obtain scientific data
United States
17 Jun 2019
FDA Finalizes Guidance On Biosimilar Interchangeability, Reiterates Case-By-Case Approach To Data Requirements
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act
United States
30 May 2019
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
FDA 2018 Year In Review (And A Few Thoughts On 2019)
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018.
United States
4 Jan 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FDA's Drug Centers Release New Draft Guidance On Quantitative Info In Consumer-Directed Ads
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps ...
United States
18 Oct 2018
FDA's New Biosimilar Action Plan Represents The Next Step for Improving Drug Competition
The BAP goes on to address the Agency's obligations to ensure the continued viability of the "virtuous cycle of innovation and competition."
United States
25 Jul 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 2017 Year In Review: Therapeutic Products Energized By Cures Act, Bold Leadership
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory...
United States
20 Dec 2017
FDA Commissioner Announces Stem Cell Enforcement Shift, Plans To Develop Comprehensive Regenerative Medicine Policies
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 ...
United States
7 Sep 2017
FDA Delays Enforcement Of Prescription Drug Product Identifier And Related Requirements
As it explains in the document, FDA's decision was spurred by comments and feedback from manufacturers and other trading partners expressing concern over industry-wide readiness...
United States
17 Jul 2017
FDA User Fee Legislation Moves Forward In Senate With Multiple Policy Riders On-Board
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process...
United States
19 May 2017
More Bipartisan Bills Hope To Catch A Ride On The UFA Reauthorization Legislation
Just as the public comment period for the bicameral, bipartisan discussion draft of the "FDA Reauthorization Act of 2017" ended on Friday, what we have been calling the User Fee Games...
United States
5 May 2017
New State Substitution Laws, And A Busy Spring For Biosimilars
We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana.
United States
24 Apr 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
Let The 2017 "UFA" Games Begin!
In the alphabet soup that is health and FDA law and policy (if you don't know what we mean, are you sure you should be reading this blog?), one acronym that doesn't get a lot of respect is "UFA."
United States
23 Mar 2017
Trump Executive Orders Create Uncertainty For Health Care & Pharmaceutical Industries
As we've previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules...
United States
17 Mar 2017
Coming Soon To A Lawbook Near You – New Cosmetic Requirements
Witnesses against the proposed legislation described chemical toxicity testing procedures already place, such as the Human Repeat Insult Patch Test.
United States
24 Oct 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 Announces Dates For Long-Awaited Public Hearing On Its Regulation Of Off-Label Communications
On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry.
United States
7 Sep 2016
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