by Mark Slisz | Aug 28, 2019
Fear. Anxiety. Sleepless nights. Terror of noncompliance. Remember those thoughts that raced through your mind when you heard a regulatory agency was going to inspect your facility? And then, multiply that by ten when you learned that not only members from the United...
by Mark Slisz | Aug 15, 2018
In July 2018, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for Industry, on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). Since the initial FDA gene therapy guidance...
by Mark Slisz | Oct 13, 2017
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with FDA. In addition, the FD&C Act requires...