Acceptance for Filing definition

Acceptance for Filing means Atrix's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section 314.101.

Acceptance for Filing means:

Acceptance for Filing means notification from the FDA indicating receipt of an NDA submission in the United States or equivalent marketing application pursuant to Applicable Laws in each country in the Territory.

Examples of Acceptance for Filing in a sentence

• The statement: "Date of Acceptance for Filing", which shall be the date the Department of Law files the plan.

• ER13-1957-001, ER13-1942-001, ER13-1946-001, ER13-1960-001, ER13-1947-001, and ER15-2200-000, Acceptance for Filing (November 19, 2015); see also ISO New England Inc., 151 FERC ¶ 61,133 (2015).

• In our full model, we find no support for this notion and also find that funders in general—with or without ties—attach a lower importance to this type of information.

• On February 2, 2017, IPCI filed a Form 6-K with the SEC attaching as Exhibit99.1 a press release entitled “Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista™ (oxycodone hydrochloride extended release), an Abuse Deterrent Analgesic for the Treatment of Moderate to Severe Pain” (the “February 2017 Press Release”).

• Common in Medieval Latin, this often creates uncertainty in the use of the accusative and ablative cases after prepositions.

More Definitions of Acceptance for Filing

Acceptance for Filing means, with respect to an NDA filed for a Product: (a) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; (b) in an EU Market, the receipt of written notice of acceptance for filing of such NDA from the EMA or the applicable national Regulatory Authority in such EU Market (as applicable); or (c) in Japan, the receipt of written notice of acceptance for filing of such NDA from the PMDA.

Acceptance for Filing means Nycomed's receipt of a letter issued by the EMEA or other Competent Authority indicating acceptance for filing of a regulatory dossier pursuant to Applicable Laws in the Territory.

Acceptance for Filing means that FDA has accepted the ANDA for the Product and an application number has been assigned by FDA to the ANDA.

Acceptance for Filing means, with respect to an IND filed for a Product: (a) in the United States, the date the IND goes into effect in accordance with 21 C.F.R. §312.40(b) (or its successor regulation); or (b) in any other country or group of countries, after filing of an IND with the applicable Regulatory Authority for such country or group of countries, the date upon which enrollment of the first subject in the applicable clinical trial of such Product may legally occur in such country or group of countries.

Acceptance for Filing means, with respect to a BLA filed for a Product in the U.S., that the FDA has accepted such BLA for substantive review as evidenced by receipt of notice from the FDA of such acceptance or other evidence that the FDA has commenced its substantive review of such BLA.

Acceptance for Filing means, following the submission of an application for Marketing Authorization made to a Regulatory Authority, the expiration of any applicable waiting period during which the Regulatory Authority has authority to issue a refusal to file, if any, as to such application.

Acceptance for Filing means that an application for Approval (or Conditional Approval in the case of Japan) of a Licensed Product for use with humans in the *Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. applicable portion of the Territory has been submitted to the Regulatory Authority for preliminary administrative review or an equivalent regulatory process to ensure that the dossier submitted is properly formatted and such application either has been expressly accepted or has been deemed accepted because it was not rejected within the time permitted by Law.