PADER definition

PADER means Periodic Adverse Drug Experience Report.
View Source
PADER means the Periodic Adverse Drug Experience Report (PADER) in accordance with the postmarketing safety reporting requirements of 21 CFR 314.80(c)(2) and 600.80(c)(2).
View Source
PADER means the Commonwealth of Pennsylvania acting by and through its Department of Environmental Resources.
View Source

Examples of PADER in a sentence

  • Until the NDA Transfer Date, Depomed shall report Adverse Drug Experience Reports, Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) in accordance with International Conference on Harmonization Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C) and 21 C.F.R. § 314.80.

  • From and after the Closing, Seller shall complete any outstanding commitments that Seller made to FDA prior to Closing with respect to Abstral, namely providing a Final Response to FDA on the issues identified in FDA Form 483 issued August 25, 2015 and a reconciled Periodic Adverse Drug Experience Report (PADER) for the period ending January 2015.

  • The EPA shall notify the Navy and PADER not less than 14 days in advance of any scheduled sample collection activity.

  • The parties shall request PADER to identify all potential ARARs as early in the remedial process as possible consistent with the requirements of CERCLA Section l21 and the NCP.

  • At the time specified as the end of each visitation period, [PADR 1 or PADER 2] must pick up the child to Residence [Parent 1 or Parent 2].

  • Buyer shall draft any responses to deficiencies the FDA identifies with respect to the Supplement, and Seller shall use Reasonable Commercial Efforts to provide Buyer with information it needs to prepare and file with the FDA the regulatory filings required to be filed by Buyer for the manufacture, marketing and distribution of the Lithobid Products, including, without limitation, the applicable PADER and NDA annual report for 2015 (with applicable domestic distribution data).

  • Until the Closing Date, Depomed shall (A) review the scientific literature for safety report information, (B) report Adverse Drug Experience Reports, Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) in accordance with International Conference on Harmonization Clinical Safety Data Management: Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • The Navy shall honor all reasonable requests for access to the Site made by EPA or PADER.

  • The Navy shall notify EPA and PADER not less that 14 days in advance of any scheduled sample collection activity.

  • Such aggregate safety reports shall be prepared in accordance with applicable regulatory requirements, and shall include without limitation the Periodic Safety Update Report (PSUR) and the Periodic Adverse Drug Experience Report (PADER).