Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is “straightforward and largely ministerial in nature.” But recent court decisions coupled with prior FDA determinations demonstrate that the calculation is not so easy. Identifying the testing phase and the approval phase can be tricky in certain circumstances.
Pepper partner Nina M. Gussack, the chair of the firm's Health Sciences Department, was named to the board of directors of Life Sciences Pennsylvania (formerly Pennsylvania Bio), the premier trade association for the life sciences industry in Pennsylvania. She was one of 10 new board members announced on May 8, 2017.
Sharon R. Klein (CIPP/US) spoke with Health IT News at the 2017 Healthcare Information and Management Systems Society Privacy and Security Forum to discuss the May 2017 global cyberattack by the WannaCry ransomware cryptoworm. The cyberattack crippled Britain's National Health Service, hit international shipper FedEx and infected computers in 150 countries.
Webinar with an authoritative panel of class action counsel discussing current trends and case law developments in food and beverage class action lawsuits. The panel will outline strategies for plaintiff and defense attorneys to increase the likelihood of success during class certification and at trial.