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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Mintz ordered by Published Date Descending.
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1
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
2
Device Modernization Series: In Vitro Clinical Tests
In our first two Device Modernization series posts, we discussed FDA's 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts
United States
18 Mar 2019
3
Independent Laboratory Settles Medical Necessity Allegations
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. ("GenomeDx"),
United States
28 Feb 2019
4
Device Modernization Series: FDA's Changes To The 510(k) Program
In our "FDA 2018 Year in Review (and a Few Thoughts on 2019)" post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program
United States
28 Feb 2019
5
Federal Circuit Dismisses Appeal Of IPR Final Written Decision For Lack Of Standing After Appellant Terminated Development Of Potentially Infringing Pharmaceutical Product
The Federal Circuit did not decide the broader issue presented by Momenta's argument, namely that the IPR estoppel provision provides sufficiently concrete injury to satisfy Article III standing.
United States
20 Feb 2019
6
Petition For Certiorari Asks Supreme Court To Clarify Whether The Federal Securities Laws Carry A Duty To Update
Last week, executives of the now-defunct biotechnology company, Orexigen, filed a petition for certiorari with the U.S. Supreme Court ...
United States
20 Feb 2019
7
45 States Now Have Biosimilar Substitution Laws
Forty-five states and Puerto Rico have now enacted laws that permit or require pharmacists to dispense an interchangeable biological product in certain situations.
United States
18 Feb 2019
8
How Much Control Do Device Manufacturers Have Over Servicing?
In December, my colleague Aaron Josephson and I described our observations after attending FDA's public workshop on Medical Device Servicing and Remanufacturing Activities.
United States
28 Jan 2019
9
Health Care Enforcement Year in Review and 2019 Outlook: Civil Litigation Developments and Settlements
As expected, extensive litigation concerning materiality has ensued.
United States
15 Jan 2019
10
340B, When A Price Adjustment Is Not Really An Adjustment, And The Implications For CMS Efforts To Attack Drug Prices
The Federal Courts gave the America Hospital Association and 340B covered entities a late Christmas present and in doing so may have dealt a blow to the Trump Administration's initiatives
United States
15 Jan 2019
11
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
12
Observations From FDA's Public Workshop On Medical Device Servicing And Remanufacturing
The second day of the workshop focused solely on potential methods of collaboration among stakeholders to improve medical device servicing.
United States
28 Dec 2018
13
Paradigm Shift: Regulating Software As A Medical Device In The U.S.
Therefore, FDA believes SaMD is different enough from hardware devices to warrant a different regulatory model.
United States
28 Dec 2018
14
Medical Products & FDA: What To Watch For In 2019
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years.
United States
10 Dec 2018
15
FDA's Refreshed Approach To Device Safety Would Require Major Changes To 510(K) Program
On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety.
United States
30 Nov 2018
16
Regulatory Challenges For The New Frontier Of Medical Imaging: Terahertz Spectrum
Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC).
United States
21 Nov 2018
17
Strategies To Unlock AI's Potential In Health Care, Part 5: Product Liability Prevention For AI Product Designers—And Their Lawyers
As our use of AI technology becomes more frequent, interconnected, and integral to daily life, the liability exposure to AI product designers and manufacturers continues to escalate
United States
16 Nov 2018
18
Changes Ahead For HIPAA?
As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda.
United States
6 Nov 2018
19
Sunshine Act Expands To Advance Practice Nurses And Physician Assistants
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act
United States
11 Oct 2018
20
ML Strategies Health Care Preview Week Of September 24th
Expect significant scrutiny of the details.
United States
28 Sep 2018
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