There are different types of generic pharmaceuticals meeting various patients’ medical needs. Some treat rare diseases such as the prescription only injection of zoledronic acid used to prevent fractures in patients with prostate cancer or multiple myeloma.

Others such as acetaminophen treat common disease such as pain.  Not all diseases have an equivalent generic pharmaceutical. Generic […]

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 […]

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 […]