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This is a list of investigational autism and pervasive developmental disorder drugs, or drugs that are currently under development for clinical use in the treatment of autistic spectrum disorders and/or other pervasive developmental disorders but are not yet approved.
The Autism Treatment Evaluation Scale (ATEC) is a 77-item diagnostic assessment tool that was developed by Bernard Rimland and Stephen Edelson at the Autism Research Institute. The ATEC was originally designed to evaluate the effectiveness of autism treatments, but it may also be beneficial as a screening tool for children.
For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
These medications were designated as specialty drugs and required specialty pharmacies. When the FDA approves a new drug they may require a REMS program which "may contain any combination of 5 criteria: Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments". [46 ...
The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S.
The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said. The drug crovalimab, branded as PiaSky, is a monthly under-the-skin ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
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related to: fda drugs requiring medication guides for adults with autism disorder checklist