Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Arnold & Porter Kaye Scholer LLP
In October, we reported that the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States in the Decentralised Procedure.
Arnold & Porter Kaye Scholer LLP
The guidelines are not intended to place any restraint on the development of new technologies.
Arnold & Porter Kaye Scholer LLP
The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of "similar medicinal product" for the purposes of the Orphan Medicinal Products Regulation.
Ropes & Gray LLP
What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?
Seyfarth Shaw LLP
The ability to facilitate the regeneration of parts of the human body is "no longer the stuff of science fiction" according to FDA Commissioner Scott Gottlieb.
Reed Smith
In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York.
Holland & Knight
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology.
Reed Smith
A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency.
Reed Smith
This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA's recent guidance on the hot topic of 3D printing as a manufacturing practice for regulated drugs and medical devices...
Reed Smith
The FDA announced the availability of its guidance entitled "Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff," ...
McDermott Will & Emery
Health-related technology is growing at an accelerating rate, as is its demand.
Marshall, Gerstein & Borun LLP
In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB's factual findings and that the claims should have been held non-obvious
Arnold & Porter Kaye Scholer LLP
On 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication...
Reed Smith
As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, "different from or in addition to," ...
Ropes & Gray LLP
In the short term, Amarin could potentially petition the commission to reconsider its dismissal of the complaint.
Davis Brown Law Firm
In last week's post, we covered initial considerations for physicians considering patent protection
Davis Brown Law Firm
Physicians are well-positioned to generate new inventions and thereby improve the treatment of their patients.
Arnold & Porter Kaye Scholer LLP
The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe.
Fenwick & West LLP
Fenwick corporate lawyer Julia Forbess discussed biotech investment and financing trends with the BIO Buzz Center at the 2017 BIO Investor Forum.
Arnold & Porter Kaye Scholer LLP
The AG has opined that CMSs can raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure.
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Davis Brown Law Firm
Physicians are well-positioned to generate new inventions and thereby improve the treatment of their patients.
Davis Brown Law Firm
In last week's post, we covered initial considerations for physicians considering patent protection
Arnold & Porter Kaye Scholer LLP
On 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication...
Fenwick & West LLP
Fenwick corporate lawyer Julia Forbess discussed biotech investment and financing trends with the BIO Buzz Center at the 2017 BIO Investor Forum.
Seyfarth Shaw LLP
In Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. November 1, 2017), the Federal Circuit overturned the District of Delaware's finding that Watson failed ...
Reed Smith
This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA's recent guidance on the hot topic of 3D printing as a manufacturing practice for regulated drugs and medical devices...
Arnold & Porter Kaye Scholer LLP
The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of "similar medicinal product" for the purposes of the Orphan Medicinal Products Regulation.
Reed Smith
This guidance highlights FDA's increasing interest in Digital Health issues
Reed Smith
As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, "different from or in addition to," ...
Ropes & Gray LLP
In the short term, Amarin could potentially petition the commission to reconsider its dismissal of the complaint.
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