My passion for FDA law was ignited when I realized, firsthand, how much of an impact medical technology has on patients and their families. I have two sisters that live with chronic diseases and conditions and rely on life-sustaining and life-saving medical devices and pharmaceuticals—one of which has endured 140+ brain surgeries and procedures and currently has 9 different implantable devices. I strive to help clients so that they can continue to make their therapies available to the patients that rely on them.
– AMANDA JOHNSTON, J.D., R.A.C.
- Compliance assessments, investigations and training
- Design and implementation of compliance programs
- Advertising and promotional review
- Business interactions with health care professionals
- Transparency reporting
- Privacy compliance
- Regulatory assessments and FDA submissions, including 510(k)s, De Novos, RFD’s, EUA’s, PMAs, IDEs, HDEs, NDAs, Pre-Submissions, Breakthrough Designations, change control supplements, and annual reports for drugs and devices