Lisa Dwyer

King & Spalding

+ Follow Contact

Latest Posts › Advisory Committee

Share:

FDA Continues its Focus on Breast Implant Safety and Transparency with an Eye Toward Improving Regulatory Decision-Making

In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more

9/1/2020 / Advisory Committee , Food and Drug Administration (FDA) , Medical Device Reports (MDRs) , Medical Devices , New Guidance , Transparency

Court Dismisses Shareholder Suit Seeking To Recover Stock Drop from FDA Nonapproval of Experimental Drug

Companies that sell products or services that cannot be marketed without regulatory preclearance, and particularly companies that develop experimental drugs and medical devices, should take note of the recent opinion by Judge...more

8/26/2020 / Advisory Committee , Dismissals , Food and Drug Administration (FDA) , Loss Causation , Medical Devices , Prescription Drugs , Putative Class Actions , Shareholders , Stock Drop Litigation

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

2/22/2019 / Advisory Committee , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturer Liability , Manufacturers , Medical Devices , Pharmaceutical Industry

3 Results

View per page

Page: of 1