May 16, 2018 Source: Ddu 88
With the unveiling of a new drug price plan by the Trump Administration, the Food and Drug Administration (FDA) will put into action a plan to infuse competition in drug markets.
A website is planned to be launched by the agency for offering exhaustive details on branded drugs which are not easily available to generic drug makers. The website will also be home to information on a retroactive basis on around 150 inquiries on around 50 brand-name medications and are anticipated in the future on an ongoing basis. While some drugs had more than one inquiries from generic drug manufacturers, others are likely to have only one.
Information on the website will shed light on drugs which require a Risk Evaluation and Mitigation Strategy (REMS) and which make the acquisition of sample development harder for generic drug companies. The FDA will make a note of the fact whether an official letter has been dispatched to the brand-name drug company.
It will also indicate which drugs require a Risk Evaluation and Mitigation Strategy (REMS) and which could make it harder for generic drug companies to acquire samples for development. The FDA will note if it sent an official letter to the brand-name drug company in the case, Gottlieb said.By editor
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