Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Ropes & Gray LLP
The January 2018 Interim Final Rule stated that the general compliance date may be subject to additional delay through further rulemaking.
Reed Smith
On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support ...
Foley Hoag LLP
Attorneys Colin Zick, Catherine Muyl and Marion Cavalier recently presented a webinar for MichBio U on what the EU's General Data Protection Regulation means for U.S.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.
Jones Day
The Organ Procurement and Transplantation Network ("OPTN")/ United Network for Organ Sharing ("UNOS") has recently modified the national lung allocation policy as a result of a court-ordered ...
Reed Smith
This one comes from Alabama and it's pretty straightforward – plaintiff's claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint.
Morgan Lewis
In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13...
Ropes & Gray LLP
The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear.
Foley Hoag LLP
Foley Hoag's Product Liability Update is a quarterly update concerning developments in product liability and related law of interest to product manufacturers and sellers.
Reed Smith
Wilson was a wrongful death case filed almost exactly two years after the death at issue.
Pryor Cashman LLP
On April 19, 2018, Partner Stephen Goodman, Co-Chair of Pryor Cashman's Life Sciences Group, will moderate a panel at the BioMEDevice Boston Conference.
Pryor Cashman LLP
On April 10, 2018, Partner Stephen Goodman, Co-Chair of Pryor Cashman's Life Sciences Group, will moderate a panel at the Redefining Early Stage Investments ...
WilmerHale
The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items...
Morgan Lewis
The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply.
Reed Smith
We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family ...
Carlton Fields
[A]n emerging health care model for disease treatment and prevention strategies that takes into account each person's genetic variations, environment and lifestyle.
Seyfarth Shaw LLP
The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018.
Haug Partners
The PTAB agreed with Broad and terminated the interference. UC appealed.
Marshall, Gerstein & Borun LLP
A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018).
Marshall, Gerstein & Borun LLP
On February 9, 2018, the PTAB denied Sandoz Inc.'s petition for inter partes review of U.S. Patent No. 9,512,216...
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Haug Partners
The PTAB agreed with Broad and terminated the interference. UC appealed.
WilmerHale
The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items...
Marshall, Gerstein & Borun LLP
On February 9, 2018, the PTAB denied Sandoz Inc.'s petition for inter partes review of U.S. Patent No. 9,512,216...
Marshall, Gerstein & Borun LLP
A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018).
Carlton Fields
[A]n emerging health care model for disease treatment and prevention strategies that takes into account each person's genetic variations, environment and lifestyle.
Reed Smith
We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family ...
Ropes & Gray LLP
The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear.
Jones Day
The Organ Procurement and Transplantation Network ("OPTN")/ United Network for Organ Sharing ("UNOS") has recently modified the national lung allocation policy as a result of a court-ordered ...
Morgan Lewis
In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13...
Thompson Coburn LLP
Recently, Thompson Coburn's Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging connected device market and discussed data...
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