Prior Approval Supplement definition

Prior Approval Supplement means a change in the manufacture or testing of the Product that may be applicable to either a specific batch of Product or all Product that requires FDA approval prior to implementation of such change or sale of the Product.
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Prior Approval Supplement has the meaning given to it in section 506A of the Federal Food, Drug, and Cosmetic Act and §314.70(b) in the Code of Federal Regulations.
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Examples of Prior Approval Supplement in a sentence

  • Notice of acceptance shall state that the acceptance is absolute or subject to conditions specified in the notice, which may include FDA lot release in situations where a Prior Approval Supplement is required by the FDA.

  • Commencing not later than the [*****] anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet Intrexon’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with Intrexon at least [*****], and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing.

  • All Changes that impact the specifications, yield, quality, etc of the API must be submitted to Reliant QA for review and approval prior to implementation as such changes may require a Prior Approval Supplement to the affected NDA.

  • Commencing not later than the *** anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet ViroPharma’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with ViroPharma at least ***, and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing.

  • With this as our backdrop, I’d like to turn the topic over to the topic of the day which is the receipt of a Complete Response Letter, or CRL, in regard to selected topics included in Bivigam’s drug substance Prior Approval Supplement to amend it’s already approved BLA.

  • The Borrower shall have obtained FDA approval of the BIVIGAM Prior Approval Supplement, and the Administrative Agent shall have received evidence satisfactory to it of such approval.

  • Aerie also plans to file a Prior Approval Supplement with the FDA in second-quarter 2020 to obtain FDA approval to manufacture Rhopressa® in Athlone for commercial distribution in the U.S. market.•The European Commission granted a centralised marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% in November 2019.

  • Where the Fujifilm regulatory assessment deems that a Prior Approval Supplement to the Dyax Biologics License Application may be required as a result of a planned new product introduction, Fujifilm will notify Dyax in writing at the earliest opportunity in order to allow consideration of the regulatory strategy and timelines.

  • Generic Rx – Pipeline Large ANDA Pipeline includes 71 products ▪ 51 can be re - commercialized via CBE30 or Prior Approval Supplement ▪ Leverage ANI’s three manufacturing sites to re - launch acquired ANDAs Key Pipeline Products Methylphenidate ER Tablets ▪ $1.3B market ▪ est.

  • It would be responding to a Complete Response Letter that was received due to the Prior Approval Supplement filing that we submitted, so the answer is yes.

Related to Prior Approval Supplement

  • Prior Approval means written ap- proval by an authorized official evi- dencing prior consent.

  • 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.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

  • Major Amendment means any change which is not a minor amendment.

  • 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:

  • Disclosure Statement Approval Order means the Final Order approving, among other things, the adequacy of the Disclosure Statement pursuant to section 1125 of the Bankruptcy Code.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • 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.

  • Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.

  • Stockholder Approval Date means the date on which Stockholder Approval is received and deemed effective under Delaware law.

  • 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.

  • Shareholder Approval Date means the date on which this Plan is approved shareholders of the Company eligible to vote in the election of directors, by a vote sufficient to meet the requirements of Code Sections 162(m) (if applicable) and 422, Rule 16b-3 under the Exchange Act (if applicable), applicable requirements under the rules of any stock exchange or automated quotation system on which the Shares may be listed on quoted, and other laws, regulations and obligations of the Company applicable to the Plan.

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • Required Consent has the meaning set forth in Section 4.4.

  • Superior Acquisition Proposal means any Acquisition Proposal containing terms which the Company Board determines in its good faith judgment (based on the advice of an independent financial advisor) to be more favorable to the Company’s stockholders than the Merger and for which financing, to the extent required, is then committed or which, in the good faith judgment of the Company Board, is reasonably capable of being obtained by such third party.

  • 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.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Required Effective Date means the relevant Initial Required Effective Date or Increased Required Effective Date (as those terms are defined below).

  • Requisite Shareholder Approval shall have the meaning set forth in Section 4.3(a).

  • Stockholder Approval means such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the stockholders of the Company with respect to issuance of all of the Warrants and the Warrant Shares upon the exercise thereof.

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Administrative Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Borrower pursuant to the terms of the Purchase and Sale Agreement and the Loan Assignment by which the Transferor effects such conveyance.

  • Initial Budget has the meaning set forth in Section 7.06(a).