Breakthrough treatment designation was intended to speed up the development and review of drugs to treat conditions that are serious or life-threatening. A sponsor must provide preliminary clinical evidence to support the claim for a breakthrough treatment designation. The required evidence should be able to demonstrate that the drug may be a significant improvement over […]
FDA fast Track designation is one of the methods CDER uses to speed up the creation and increase the approval of novel drugs. Along with it the following methods are also used.
•Priority Review,
•Breakthrough, and
•Accelerated Approval process.
How FDA fast track designation helps to speed up drug development
A process is followed to determine if a drug merits […]
Good clinical practice training is essential for anyone involved in testing medicines on human volunteers. Good Clinical Practice (GCP) is an ethical and practical standard for the protection of the welfare of all clinical study participants including the integrity of the data collected.
Who needs Good clinical practice training
All the personnel involved in any way during […]
Written by Ezra de Leon
Orphan drugs are drugs that treat rare diseases that are life-threatening, seriously debilitating, or cause serious and chronic conditions that affects only a relatively small number of patients.
Rare or ‘orphan’ diseases in Canada are those which affect less than 5 in 10, 000 people. About 6,000 to 8,000 rare diseases have […]
