Extension of comments for Draft FDA Circular on Interim Guidelines for the Issuance of Foreign cGMP Clearance
Please be informed that the CDRR is extending the deadline from 10 June 2020 at 3:00PM to 11 June 2020 at 5:00pm of soliciting for comments from the concerned stakeholders on the […]
Development of Drugs and Vaccines
Clinical Trial Application Process
Dapat bang uminom ng gamot tulad ng Hydroxychloroquine o Chloroquine para maiwasan ang COVID-19?
For your Information.
Should I take medicine like Hydroxychloroquine or Chloroquine to prevent COVID-19?
For your Information.
Media Announcement of Seapharma International, Inc. on the Recall of Affected Batches of Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)
SUMMARY Reason for Announcement: Out-of-Specification (Failed Assay) in the Laboratory Analyses Marketing Authorization Holder (MAH): Seapharma International, Inc. Product Description: Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 […]
List of Authorized Biosimilars (as of 1 January 2019)
The first regulation on pharmaceuticals was in 1989 this include registration of vaccines. In 2001 the specific regulation of vaccines and biological products was signed into law, this provides guidance […]
CDRR Officers of the Day for 9-11 and 13 December 2019
In view of the Performance Review and other FDA activities scheduled on 9-11,13 December-2019, please be- informed that there will be no CDRR officers on duty for the said dates […]
#MedSafetyWeek (28 November 2019)
New problems in a patient on multiple medications may be side effects or interactions. Is your patient taking too many products? Review their prescriptions and report any side effects: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH […]
VAT-Exempt Drugs List
Vat-Exempt Drugs List for Hypertension, Diabetes and High Cholesterol Please see FDA Advisory No. 2019-122 for your reference.