Final FDA Approval definition

Final FDA Approval means approval of a Product by the FDA pursuant the Federal Food, Drug, and Cosmetic Act § 505(b), 21 U.S.C. 355(b).
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Final FDA Approval shall have the meaning assigned to such term in Section 6.1.
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Final FDA Approval means approval from the FDA that would allow a party to market and sell a Generic Equivalent.
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Examples of Final FDA Approval in a sentence

  • Eagle Pharmaceuticals Receives Final FDA Approval for Pemfexy™ (Pemetrexed for Injection).

  • The Seragen Board concluded that the Merger Consideration is fair and favorable even after allowing for the contingent nature of the Milestone Consideration, since the value of Seragen would be severely compromised if Final FDA Approval were not to be forthcoming on a timely basis.

  • Prior to the Second Closing the Company shall have received the Primsol Solution Final FDA Approval.

  • Except as provided under Section 2.3 of this Agreement, the ACTIQ Patent Rights License granted pursuant to Section 2.1 (a) (i), (ii) and (iv) shall become effective upon the earliest of: (1) Final FDA Approval of OVF, (2) September 5, 2006, if Cephalon is not granted Pediatric Exclusivity with respect to ACTIQ, or (3) February 3, 2007, if Cephalon is granted Pediatric Exclusivity with respect to ACTIQ.

  • In addition, the Milestone Consideration will only be paid if Final FDA Approval is received by the Second Closing Anniversary.

  • Early Final FDA Approval / Waiver of Regulatory or Statutory Exclusivities Subject to the terms and conditions of this Term Sheet, Adamas will grant a waiver of any regulatory or statutory exclusivities to the extent necessary to effectuate the License and the Adamas Covenant, and solely for offering for sale, sale and use of the Sandoz Product in the Territory as of the Orphan Drug Date (“Exclusivity Waiver”).

  • The following estimates are dependent upon assumptions which could change in the next financial year and have a material effect on the carrying amounts of assets and liabilities recognised at the balance sheet date:Pension and other post-employment benefit obligationsThe cost of defined benefit pension plans and other post- employment benefits is determined using actuarial valuations.

  • Ligand has also agreed not to make any change prior to the Milestone Date with respect to the manufacturing processes, standard operating procedures, work force or facilities and equipment of the Surviving Corporation or Marathon that could reasonably be expected to adversely affect the prospects for, or delay, the receipt of Final FDA Approval.

  • Prior to the Second --------------------------------------- Closing the Company shall have received the Primsol Solution Final FDA Approval.

  • Avadel Pharmaceuticals Announces Final FDA Approval of Lumryz™ (Sodium Oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy.


More Definitions of Final FDA Approval

Final FDA Approval means approval by the FDA under Section 505(b) of the U.S. Federal Food, Drug and Cosmetic Act.
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Final FDA Approval means receipt from the United States Food and Drug Administration ("FDA") of such approval as is commercially permissible and legally advisable to permit a third party to begin the marketing, distribution in interstate commerce and selling of DepoCyt in the United States.
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Related to Final FDA Approval

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Development approval means any written authorization from a

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Final Approval Hearing means the hearing to be conducted by the Court to determine the fairness, adequacy, and reasonableness of the Settlement pursuant to Federal Rule of Civil Procedure 23 and whether to issue the Final Approval Order and Judgment.