1983 orphan drug act

Drugs and the QT - UKMi

• The clinical significance of QT prolongation • Causes of QT prologation • Mechanism of drug-induced QT effect • Prescribing advice for ‘QT Drugs’

March 13th,2019

Clarification of Orphan Designation of Drugs and Biologics ...

2. If a disease is common (i.e., the prevalence of the disease is 200,000 or greater), a drug may be eligible for orphan designation for a valid orphan subset 3of the disease. For example, if the ...

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM...
March 13th,2019

MeDicines in DevelopMenT 2013 Rare Diseases - PhRMA

2 Medicines in Development Rare Diseases 2013 innovative orphan Drugs in the pipeline for Rare Diseases The 452 medicines and vaccines in development for rare dis-eases employ exciting new scientific and technical knowledge.

phrma-docs.phrma.org/sites/default/files/pdf/Rare_Diseases_2013.pdf
March 13th,2019

Laws Enforced by the FDA and Related Statutes

Laws Enforced by the FDA and Related Statutes Prescription Drug User Fee Act (PDUFA) of 1992 PL 102-571 (Oct. 29, 1992) More information about PDUFA

gmptrainingsystems.com/files/u1/pdf/FDA_Laws_0.pdf
March 13th,2019

Coverage of Experimental and Investigational Procedures

Coverage of Experimental and Investigational Procedures Policy Aetna covers experimental or investigational technologies (i.e., drugs, procedures and devices) when ALL of the

www.aetna.com/members/individuals/health/plan_details/NewYork/...
March 13th,2019

Rare Diseases: Common Issues in Drug Development …

1212399dft.docx 01/30/19 Rare Diseases: Common Issues in . Drug Development. Guidance for Industry . DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory...
March 13th,2019

1. PHARMACEUTICAL LAWS - 日本製薬工業協会

Pharmaceutical Regulations in Japan: 2017 15 CHAPTER 2 PHARMACEUTICAL LAWS AND REGULATIONS 1. PHARMACEUTICAL LAWS Pharmaceutical administration in Japan is based

www.jpma.or.jp/english/parj/pdf/2017_ch02.pdf