FDA Advisory No. 2017-270
Invitation to Present Submitted Petitions and Corresponding Evidences in connection with the Re-certification of Contraceptive Products
On 21 August 2017, the Food and Drug Administration (FDA) issued Advisory No. 2017-253 to invite interested parties to submit their petitions and any corresponding evidence on the mechanism of action of the listed contraceptive products within ten (10) calendar days. At the end of the submission period, several parties expressed their interest to formally present their evidence in support of their petition/opposition/position.
In response to these requests, the FDA hereby opens the following dates for presentation of evidence to be held at Room 111, 1st Floor, FDA Main Building:
• 25 September 2017, Monday at 9:00 am to 12:00 pm
• 27 September 2017, Wednesday at 1:00 pm to 4:00 pm
Subject: Presentation of Petitions and Evidence in connection with the Re-certification of Contraceptive Products
Name of Participant: Name of Association/Marketing Authorization Holder [MAH], etc.
Category: Petitioner, or MAH, etc.
Name Attendees: Please limit to five attendees per association/MAH
Contact No(s): (+63) 917-123-45-67
A confirmation slip will be sent by email. The confirmation slip shall be presented at the reception on the day of the presentation of evidence. Only participants indicated on the list of confirmed attendees shall be accommodated. To assure all parties are given equal opportunity to present their evidence, each confirmed party is guaranteed one (1) hour to present them.
For information and guidance.