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Partner, Washington, D.C.
Lynn Whipkey Mehler is a partner in our Washington, D.C. office, advising clients on pharmaceutical products.
Lynn served for 12 years with the Food and Drug Administration's Office of the Chief Counsel, most recently as a Senior Counsel for Drugs. As one of the primary attorneys advising the agency on drug safety matters, Lynn has extensive experience in the agency's use of Risk Evaluation and Minimization Strategies (REMS), required post-approval clinical studies and trials, and required safety label changes. In addition, Lynn was the primary attorney handling all FDA issues related to controlled substances and the Controlled Substances Act. She has also advised the agency on drug approvals and withdrawals, the Prescription Drug User Fee Act, Advisory Committees, clinical investigator disqualification, and federal preemption matters.
19 February 2014
"DEA and FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014," The Food and Drug Law Institute Conference
13 February 2012
"Controlled Substance Regulation: Understanding FDA and DEA Missions, Rules & Policies," The Food and Drug Law Institute Conference
Hogan Lovells Publications
09 July 2012
"President to sign Food and Drug Administration Safety and Innovation Act: Summary of certain key provisions." Health Alert, Hogan Lovells
29 June 2011
"Preemption Defense Available to Generic Drug Manufacturers." Hogan Lovells Alert, Hogan Lovells
11 April 2011
"U.S. Supreme Court MATRIXX Decision Rejects Statistical Significance as Bright-Line Test of Materiality." SEC Update, Hogan Lovells
"Controlled Substances: FDA and DEA Regulation of Pharmaceuticals." The Food and Drug Law Institute