Call Us Today! 18002435596 Fax:18554466999

Three reasons for generic pharmaceuticals review delays

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 […]

By |February 5th, 2016|new drugs|Comments Off on Three reasons for generic pharmaceuticals review delays

Breakthrough treatment

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 […]

By |January 27th, 2016|new drugs|Comments Off on Breakthrough treatment

FDA Fast track designation

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 […]

By |January 25th, 2016|new drugs|Comments Off on FDA Fast track designation

Orphan Drugs in Canada

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 […]

By |January 7th, 2016|new drugs|Comments Off on Orphan Drugs in Canada