HPM partner McNamara dies: Stephen H. McNamara, a partner in the Hyman, Phelps & McNamara law firm and a congressional advisor on the Dietary Supplement Health and Education Act, died Dec. 28 of complications from cancer at the age of 66. McNamara's wife Caroline, children Matthew and Deborah and six grandchildren survive him. He was a member of HPM from 1984 until poor health forced his withdrawal from practice in 2003. He advised Congress in the development of DSHEA, which passed in 1994. Prior to joining HPM, McNamara was senior vice president and general counsel for the Cosmetic, Toiletry and Fragrance Association (now the Personal Care Products Council). He also was a staff attorney at FDA, a senior trial attorney and the associate chief counsel for food. He served as acting chief counsel for about a year and was twice given the FDA Award of Merit, the agency's highest service award. McNamara served as a chaplain's assistant in the U.S. Army from 1967-1969, and was awarded the Bronze Star, the Purple Heart and the Army Commendation Medal
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
