viernes, 18 de mayo de 2018

FDA publishes list of inquiries from prospective generic drug applicants about RLD access

FDA has received numerous inquiries from prospective generic applicants indicating that they are interested in developing a generic version of a drug product, but are unable to obtain samples of the reference listed drug (RLD) necessary to support their applications because of limitations on distribution of the RLD. These inquiries involve both drug products that are subject to Risk Evaluation and Mitigation Strategies (REMS) impacting distribution and products that are not subject to a REMS impacting distribution, but for which RLD sponsors have imposed voluntary distribution restrictions. To provide transparency regarding these inquiries, the agency has published a list of all drug products about which FDA has received these kinds of inquiries related to RLD access, along with details including the name of the applicable RLD sponsor, the number of RLD access inquiries FDA has received about the product, and whether FDA has communicated directly to the RLD sponsor at the generic company’s request (as further explained on the website itself, such a communication is voluntary and is only an option for certain products).  
FDA will update this list on a semi-annual basis.
The agency published this list as part of the Drug Competition Action Plan, which seeks to expand access to safe, high quality, effective generic medicines that can help consumers lower their health care costs.

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