Examples of orphan in a sentence
There is a serious disconnect between FDA’s narrow view of exclusivity in this case and the broad statutory directive that the agency has frequently invoked over the years.Because the Orphan Drug Act and its implementing regulations required FDA to grant Depomed marketing exclusivity for Gralise upon the product’s approval for its orphan- designated indication, PHN, Depomed is entitled to summary judgment in its favor.
For General and EWS Category Candidates from Maharashtra State and all candidates from Outside Maharashtra State (OMS)Rs.1000/-For Candidates of Backward Class Categories [SC, ST, VJ/DT- NT(A), NT(B), NT(C), NT(D), OBC, SBC] Rs.800/-For Orphan and Other Gender candidatesRs.800/- Candidates will be required to submit the Caste Certificate, Caste Validity and Non Creamy Layer Certificate, if applicable, at the Time of filling in CAP Application Form to be considered under the Category.
These drugs received orphan exclusivity because they met the standard in the Orphan Drug Act, not because FDA analyzed whether they provided a “benefit to the patient population beyond what is already widely available.” Opp.
The Contractor will use Class A cement to plug wells known to produce hydrogen sulfide.SCOPE OF WORK EXPLORATORY 2024 PROJECT Re-OfferMultiple Orphan Well Sites Multiple Locations and API DETAILED SPECIFICATIONS The Contractor is reminded to review the Scope of Work documents carefully.
In its brief, FDA claims it does not need to point to a clear statutory hook for its clinical- superiority requirement because Congress gave FDA “general authority to promulgate substantive, binding regulations for the FDCA,” of which the Orphan Drug Act is a part.