Food and Drug Administration Safety and Innovation Act
GPTKB entity
Statements (53)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legislation
|
| gptkbp:addresses |
safety issues in drug approval
|
| gptkbp:amended_by |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:effective_date |
gptkb:2012
|
| gptkbp:enacted_by |
gptkb:legislation
|
| gptkbp:encourages |
development of rare disease treatments
|
| gptkbp:enhances |
patient access to therapies
|
| gptkbp:facilitates |
collaboration between FDA and industry
|
| https://www.w3.org/2000/01/rdf-schema#label |
Food and Drug Administration Safety and Innovation Act
|
| gptkbp:impact |
gptkb:Company
medical device industry |
| gptkbp:improves |
transparency in drug approval process
|
| gptkbp:includes |
provisions for the review of mobile health applications
provisions for the review of diagnostic imaging devices provisions for the review of laboratory developed tests provisions for accelerated approval provisions for breakthrough therapies provisions for fast track designation provisions for priority review provisions for the review of antimicrobial drugs provisions for the review of biosimilars provisions for the review of cancer drugs provisions for the review of combination therapies provisions for the review of diagnostic tests provisions for the review of generic drugs provisions for the review of home-use tests provisions for the review of implantable devices provisions for the review of orphan drugs provisions for the review of pediatric drugs provisions for the review of point-of-care tests provisions for the review of rare disease drugs provisions for the review of surgical devices provisions for the review of telehealth services provisions for the review of wearable devices provisions for the review of digital health products provisions for the review of software as a medical device. |
| gptkbp:includes_provisions_for |
pediatric studies
drug shortages expedited review processes user fees for drug and device applications |
| gptkbp:promotes |
innovation in drug development
|
| gptkbp:purpose |
to enhance the FDA's ability to regulate drugs and medical devices
|
| gptkbp:related_to |
FDA Reauthorization Act
Medical Device User Fee Act Prescription Drug User Fee Act |
| gptkbp:requires |
FDA to develop guidance on combination products
annual reports from the FDA FDA to establish a framework for regenerative medicine |
| gptkbp:signed_by |
gptkb:President_Barack_Obama
|
| gptkbp:supports |
biologics regulation
|
| gptkbp:bfsParent |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:U._S._Food_and_Drug_Administration |
| gptkbp:bfsLayer |
4
|