[ Price : $8.95]
The Drug and Device Law Blog praises a recent federal court decision protecting some company corporate integrity agreement documen...[ Price : $8.95]
FDA issues a special controls guideline to support classification of a tryptase test system into Class 2 (special controls).[ Price : $8.95]
Attorneys John Lavelle and Jacqueline Gorbey say medical device companies should ensure that they provide technical support reques...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: ANDA Submissions Refuse-to-Receive Standards.[ Price : $8.95]
FDA advisory committee members call for new language in testosterone labeling.[ Price : $8.95]
Teva voices support for an FDA public process to address issues relating to 180-exclusivity.[ Price : $8.95]
FDA posts a new Web-based training course on Chemistry, Manufacturing, and Controls Perspective of the Investigational New Drug Ap...[ Price : $8.95]
Baxter International recalls one lot of potassium chloride injection 10mEq per 100mL due to a labeling error on the shipping carto...