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Designating an Orphan Product: Drugs and Biological …
- https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
- Sponsors may submit orphan drug designation requests one of three ways: Through the CDER NextGen portal By emailing the required information to [email protected] By mailing the required...
Providing Medical Information for Orphan Drugs
- https://link.springer.com/article/10.1177/0092861511427696
- Orphan drug medical information staff has greater visibility and is more likely to be contacted regarding adverse events and assistance for investigator-initiated …
Providing Medical Information for Orphan Drugs - SAGE …
- https://journals.sagepub.com/doi/full/10.1177/0092861511427696
- Providing Medical Information for Orphan Drugs SeanTurbeville, PhD[email protected], David A.Wells, PhD, RPh, and Carl S.Hornfeldt, PhD, RPh Volume …
Orphan Products: Hope for People With Rare Diseases
- https://www.fda.gov/drugs/information-consumers-and-patients-drugs/orphan-products-hope-people-rare-diseases
- An orphan disease is defined as a condition that affects fewer than 200,000 people nationwide. This includes diseases as familiar as cystic fibrosis, Lou Gehrig's disease, …
Providing Medical Information for Orphan Drugs - Sean …
- https://journals.sagepub.com/doi/abs/10.1177/0092861511427696
- Medical information departments are responsible for providing information regarding the drugs the company manufactures and the diseases these drugs treat. The …
Orphan Drugs | HRSA - Health Resources and Services …
- https://www.hrsa.gov/opa/program-requirements/orphan-drug-exclusion
- Orphan Drug Designation List Governing October 1 to December 31, 2021 (XLSX - 428 KB) About the Orphan Drug List. HRSA develops this list and updates it …
What is an orphan drug? - Drugs.com
- https://www.drugs.com/medical-answers/orphan-drug-3562491/
- Orphan Drug Act. Developing a drug for a rare condition that treats a very small population can be costly. In order to spur pharmaceutical companies to develop …
Providing Medical Information for Orphan Drugs
- https://www.researchgate.net/publication/254087834_Providing_Medical_Information_for_Orphan_Drugs
- The 1983 Orphan Drug Act was designed in response to market and regulatory disincentives that limited industrial interest in developing drugs needed by …
Providing Medical Information for Orphan Drugs
- https://www.semanticscholar.org/paper/Providing-Medical-Information-for-Orphan-Drugs-Turbeville-Wells/e95175c2543551cddaaef013f5e7b4c6622c50fb
- Orphan drug medical information staff has greater visibility and is more likely to be contacted regarding adverse events and assistance for investigator-initiated clinical …
Medicare Part D Coverage and …
- https://www.ncbi.nlm.nih.gov/books/NBK56190/
- To increase incentives for manufacturers, the Orphan Drug Act (P.L. 97-414) provides the following provisions for drugs that receive an orphan drug indication 1 from the U.S. …
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