Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Duane Morris LLP ordered by Published Date Descending.
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FTC Issues Report On Its Authority Under Section 5 Of The FTC Act To Challenge Pharmaceutical Drug Price Increases
On June 24, 2019, in response to a directive from Congress, the Federal Trade Commission (FTC) issued a report to the House and Senate Appropriations Committees on the use of the FTC's
United States
30 Jul 2019
Supreme Court Rules That Judges Must Decide Preemption Of Failure-To-Warn Claims
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries,
United States
7 Jun 2019
FDA Releases Draft Guidance on Voluntary Recalls
The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls.
United States
30 May 2019
VIETNAM – PHARMACEUTICALS – ASEAN IN CONTEXT – Come To Vietnam – You Will Be Treated Just – Think No More Of Indonesia
Any pharmaceutical product not being made in Indonesia must obtain a compulsory license, according to a recent new regulation adopted in Jakarta.
4 Apr 2019
DOJ Implements Granston Memo: Motions To Dismiss Filed In 11 False Claims Act Cases
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) cases to seek dismissal of qui tam complaints that threaten the government's interests.
United States
9 Jan 2019
FDA Announces New UDI Compliance Deadlines Via Another Guidance Document
On September 24, 2013, the Food and Drug Administration (FDA) issued a "final" rule regarding the Unique Device Identification System to adequately identify devices through distribution and use
United States
4 Jan 2019
FDA Withdraws Proposed Generic Drug Labeling Rule
The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels...
United States
27 Dec 2018
Healthcare And Medical Devices – Investment – With Outlook On The Major Trade Agreements CPTPP, EUVNFTA And Investment Protection Agreement
There is no denying that Vietnam truly is an attractive investment destination in South East Asia.
14 Dec 2018
New FDA Draft Guidance On Uncertainty Considerations In Benefit-Risk Determinations For Medical Device Premarket Approvals
FDA provides authorization for marketing a device when its benefits outweigh its risks.
United States
30 Nov 2018
FDA Publishes Redraft Of 510(K) Third Party Review Program
Section 523 of the Federal FD&C Act codifies the 510(k) Third Party Review Program, which authorizes certain qualified third parties to conduct the initial review of premarket notification submissions...
United States
23 Nov 2018
FDA Rolls Out Pilot Of New Quality In 510(k) "Quik" Review Program
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)).
United States
23 Oct 2018
FDA Estimates For Formal Meetings Show Continued Growth Of Biosimilars In The United States
Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the FDA to gain insight on moving a clinical development program for a proposed biosimilar product forward.
United States
4 Oct 2018
FDA Estimates For Formal Meetings Regarding Development Of Biosimilars Show Continued Growth Of Biosimilars In The United States
The importance of taking advantage of meetings with FDA during the biosimilar development process cannot be emphasized enough.
United States
3 Oct 2018
Biotech Venture Between U.S. And Cuba To Develop New Cancer Treatments
New York Governor Andrew Cuomo recently announced the formation of the first-ever biotech venture between the U.S. and Cuba.
United States
1 Oct 2018
Computer Analytics May Substantially Reduce Risk Of Surgical Infections
Infections caused by surgical procedures are not uncommon and can be life-threatening.
United States
12 Sep 2018
FTC Recommends Ways To Increase Competition And Stimulate Growth In Biosimilars And Interchangeable Market
The Federal Trade Commission (FTC) recently provided comments on the Department of Health and Human Services' (HHS) Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
United States
10 Aug 2018
Open Source Pitfalls At The Biotechnology-High Technology Crossover
Software is eating the biotechnology world. Managers in the traditional biotechnology sector may not be familiar with open source software and related compliance issues, but these issues are bound to come up ...
United States
18 Jul 2018
Drug And Device Developers Should Be Aware Of The Expanded Access Policy Requirement Under The 21st Century Cures Act
With Congress's recent passage of the 21st Century Cures Act (the "Cures Act") by an overwhelming majority, and President Obama's anticipated signing of the bill, we expect that the Cures Act will soon become law. The Cures Act is intended to accelerate development and FDA approval of medical innovations such as cancer treatments, precision medicine and regenerative medicine.
United States
10 Dec 2016
FDA Issues Final Hatch-Waxman Regulations
The FDA issued a Final Rule to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, entitled "Abbreviated New Drug Applications and 505(b)(2) Applications."
United States
13 Oct 2016
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