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1
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
2
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
3
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
4
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
5
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
6
FDA's Drug Centers Release New Draft Guidance On Quantitative Info In Consumer-Directed Ads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
7
Biosimilars Action Plan Update: Public Hearing Scheduled
As an immediate follow-up to last week's release of the FDA's Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on ...
United States
26 Jul 2018
8
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
9
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
10
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
11
FDA Alters Course On Definition Of Compounding "Facility" In Final Guidance
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride ...
United States
16 May 2018
12
FDA's Approach to Regenerative Medicine – Joanne Hawana, Of Counsel, Health Law Practice (Video)
Joanne Hawana discusses recent actions taken by FDA with regard to regenerative medicine including clarifying what technologies fit within the rubric, the announcement of a wholesale review of polices...
United States
5 Feb 2018
13
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
14
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
15
FDA Resets Enforcement Priorities For OTC Homeopathic Drugs
Happy New Year! And now on to your regular Consumer Product Matters programming…
United States
4 Jan 2018
16
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
17
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
18
A "Surprise" Cosmetic Reform Bill Appears In Congress; Bipartisan Compromise Continues To Be Legislators' Goal
As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future.
United States
17 Nov 2017
19
OTC Drug Manufacturers: Keep Your Eyes And Ears On Congress
. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on its ideas.
United States
17 Oct 2017
20
Federal Trade Commission Announces Workshop On Competition In The Prescription Drug Market
On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, "Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics."
United States
17 Oct 2017
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