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Tag: FDA Announcement
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FDA Announcement
In the interest of service and in recognition of the continuing challenges and efforts to address the COVID-19 pandemic, the Food and Drug Administration hereby extends the effectivity of Memorandum Circular No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing
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FDA Announcement
No Face to Face Interaction at the Food and Drug Action Center (FDAC) on 24 August 2020, Monday, Until Further NoticeThe alarming increase in the number of infections due to COVID-19 poses a threat to the health and safety of employees and clients of FDA. With the recent developments, FDAC will not accept clients on
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FDA Announcement
Draft Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products” OBJECTIVE: This Circular aims to: 1. Establish the guidelines for the
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FDA Citizen’s Charter
FDA Citizen’s Charter for Comments Please see the following Drafts for Comments of FDA Citizen’s Charter: FDA Citizen’s Charter – CSL–>https://bit.ly/3i6lsjrFDA Citizen’s Charter – CDRR–>https://bit.ly/2XlYs7QFDA Citizen’s Charter – CCRR–>https://bit.ly/39QLu7bFDA Citizen’s Charter – CFRR–>https://bit.ly/33g2lzcFDA Citizen’s Charter – CDRRHR–>https://bit.ly/33lMChW Post from Food and Drug Administration.
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Food and Drug Administration Update
For your information and guidance! Post from Food and Drug Administration.
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FDA Advisory
FDA Advisory No. 2020-1374 || ADVISE ON THE USE OF FACE MASK WITH VALVE The Food and Drug Administration (FDA) is strongly advising the public that the use of a facemask with a valve is not recommended during this COVID-19 pandemic. The person wearing the mask with a valve can be protected from the virus.
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FDA Circular
FDA Circular No. 2020-006-B || FURTHER AMENDMENT TO THE FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020 AND ITS AMENDMENT ISSUED ON 2 APRIL 2020 SCOPE AND COVERAGE This Circular shall cover all stakeholders applying
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FDA Announcement
Please be advised that starting tomorrow, 04 June 2020 until Monday, 15 June 2020, our FDAC Landline numbers will be temporarily disabled in preparation to the upgrade of our telephone system. In the meantime, you may reach us thru the following contact numbers: Mobile: GLOBE/TM: 0956-45182680956-45183410953-16095500935-48595830977-61779910977-6177994SMART: 0961-68044470951-13111860961-05749260961-0574927 Email: fdac@fda.gov.ph Operating hours from 9AM to 4PM
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FDA Circular
FDA Circular No. 2020-017 || Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058 Consistent with Department Memorandum No. 2020-0058 dated 31 January 2020, Department Memorandum No. 2020-0058-A dated 11 February 2020, Department Memorandum No. 2020-0058-B dated 05 March 2020, and Department
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***FDA Advisory No. 2020-513***
The Food and Drug Administration (FDA) has now approved the Real-Time PCR for the detection of COVID-19 manufactured by the Manila HealthTek, Inc. for commercial use. The test kit was previously approved by the FDA for field trial. with gene sequencing on 10 March 2020. Upon the company’s submission of necessary requirements today, the FDA
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