Newsletter - October 3, 2019
FDA Reorganization Highlights New Realities for the Industry
For the last two years, FDA’s Center for Drugs (CDER) is being reorganized to address the complexity of the products it regulates. These reorganization, termed “modernization”, has been presented by FDA as internal changes that will not affect ongoing and upcoming reviews of applications but there are... Read More
23 & Me Gets Into Clinical Trial Recruitment Testing the Privacy of Consumers
Genetic tests such as those conducted by “23 and Me” reveal some of the most intimate health-related information about a consumer. And now 23 and Me has decided to use this information to pitch clinical trials to its consumers which should worry any privacy conscious consumer. Read More
FDA Reorganization Highlights New Realities for the Industry
For the last two years, FDA’s Center for Drugs (CDER) is being reorganized to address the complexity of the products it regulates. These reorganization, termed “modernization”, has been presented by FDA as internal changes that will not affect ongoing and upcoming reviews of applications but there are... Read More
23 & Me Gets Into Clinical Trial Recruitment Testing the Privacy of Consumers
Genetic tests such as those conducted by “23 and Me” reveal some of the most intimate health-related information about a consumer. And now 23 and Me has decided to use this information to pitch clinical trials to its consumers which should worry any privacy conscious consumer. Read More