Tentative Approval definition
Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.
Tentative Approval means the approval granted by the Authority pursuant to the requirements as specified in Section 105 and which does not constitute a reservation of capacity or service from the Authority but shall signify that upon submission of a request for Final Approval and compliance with the requirements as specified in Section 105, final Approval may be granted by the Authority.
Tentative Approval means, with respect to any Product, the tentative FDA Approval of the ANDA of Impax with respect to such Product.
Examples of Tentative Approval in a sentence
An estimate of such charges will be provided to Focal in the Tentative Approval.
On September 30, 1982, the U.S. Department of Interior, Bureau of Land Management (BLM) rescinded Tentative Approval to the state on Sections 12 and 13 of the lease.
An estimate of such charges will be provided to Requesting Carrier in the Tentative Approval.
For those requests submitted prior to March 1st, the Employer will provide Tentative Approval or denial by March 15th.
Provided that they are substantially consistent with the Settlement Plan, final plans for Stages II, III and IV shall be reviewed and approved under the terms of this Agreement and the Smithfield Township Zoning Ordinance No. 38 in effect at the time of the 1988 Tentative Approval.
More Definitions of Tentative Approval
Tentative Approval means, as applicable, the tentative FDA approval of the Teva ANDA.
Tentative Approval means that the proposed generic has been deemed by the FDA to be safe, effective and bioequivalent to its brand name counterpart, but the existence of some unexpired legal or regulatory barrier (such as Orphan Drug exclusivity) precludes the FDA from
Tentative Approval means that although existing patents and/or marketing exclusivity prevent the ap- proval of the product in the United States at this time, the product meets all of the FDA’s normal requirements for manufacturing quality and clini- cal safety and efficacy. The agency says it performs all of its reviews of applications received in association with the Emergency Plan on an expe- dited basis; the agency reviewed this application for lamivudine tablets in
Tentative Approval means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco®, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. As a result of the FDA determination, the Agency cannot give final approval for Libervant until the expiration or inapplicability of the orphan drug market exclusivity, including, for example, by court order, a selective waiver of the orphan drug exclusivity, or a reversal of the FDA’s decision and determination that Libervant is “clinically superior” to Valtoco.
Tentative Approval means that the proposed generic has been deemed by the FDA to be safe, effective and bioequivalent to its brand name counterpart, but the existence of some unexpired legal or regulatory barrier (such as Orphan Drug exclusivity) precludes the FDA from granting final approval. Put another way, the approval would be final and not “tentative” but for the unexpired regulatory exclusivity.
Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the US. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the US.
Tentative Approval means approval of the Handbook for the entire Project approved by the City Council pursuant to the Tentative Approval process under the Planned Development Law, resulting in a “Tentatively Approved Handbook.”