As specified in Section 505(b)(2) of the FD&C Act, the current FDA process for evaluating biosimilar protein and peptide drugs in a marketing application allows the follow-on applicant to rely, in part, on available know-ledge about the safety and effectiveness of the structurally similar, already approved product.
The US Orphan Drug Act has fostered the development of drugs for patients with rare diseases by granting 'orphan designations', although several orphan drugs for which a marketing application has been submitted to the FDA have failed to obtain approval.
"In the past, some drug manufacturers expressed concern that a not-approvable letter sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital," the F.D.A. said in a 122-page overview of its new policies.
Dialogue with the FDA is encouraged during early stages of product development in order to provide investigators and sponsors with an understanding of what is needed to initiate clinical development, and at later stages to discuss what type of data would be needed to support a marketing application.
For example, when she started, the countries under her purview had no written process explaining how to file a new-drug application or a marketing application.
And without missing a beat, in March Benjamin led a $15 million round of financing for CoreMetrics, a marketing application service provider.
On the day I spoke with her, she had just met with a company about a marketing application for one of its products--the end of the line for a compound making its way through the regulatory process.
ImClone Systems said Friday it would take a $30.3 million charge for taxes on stock options exercised by executives; it also said it would submit a marketing application this year for its experimental cancer drug.
The study also showed that among companies submitting a marketing application to EMA, large companies requested SA most frequently and were more adherent to the advice than medium-sized and small companies [ 9].
