FDA Circular No.2017-013-A || AMENDMENT TO FDA CIRCULAR NO. 2017-013, ENTITLED, “GUIDELINES ON THE ISSUANCE OF CLEARANCE FOR CUSTOMS RELEASE (CFCR) OF RADIATION DEVICES BY THE FOOD AND DRUG ADMINISTRATION – CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH (FDA-CDRRHR)”
I. BACKGROUND FDA Circular No. 2017-013: “Guidelines on the Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food and Drug Administration – Center for Device Regulation, […]
FDA Circular No.2022-005 || Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP)
I. BACKGROUND It is the policy of the state to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures […]
FDA Circular No.2022-004 || Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals”
I. BACKGROUND As pharmaceutical supply chains become more globalized and complex, regulatory oversight increases as well in complexity, on top of an increasing need for financial and technical resources. It […]
FDA Circular No.2022-003 || Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes
I. BACKGROUND/RATIONALE According to the World Health Organization Fact Sheets on Mercury and Health, mercury is considered as one of the top ten chemicals or groups of chemicals of major […]
FDA Circular No.2022-002 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted during the 34th ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings
I. BACKGROUND In 2005, the Department of Health (DOH) – Food and Drug Administration (FDA), then Bureau of Food and Drugs (BFAD), has adopted and implemented the Association of Southeast […]
FDA Circular No.2020-029-A || Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials”
The Inter-Agency Task Force for the Management of Emerging Infectious Diseases has issued Resolution No. 160 Series of 2022 dated 03 February 2022 wherein it was resolved, among others, that […]
FDA Circular No.2021-002-B || Amendment to FDA Circular No. 2021-002-A entitled “Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements””
I. RATIONALE On 9 August 2021, FDA Circular (FC) No. 2021-002-A entitled “Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the […]
FDA Circular No.2022-001 || Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research” dated 09 February 2021
I. BACKGROUND Through FDA Circular (FC) No. 2021-004, the Food and Drug Administration (FDA) issued the interim guidelines for the issuance of License to Operate (LTO) and Certificate of Product […]
FDA Circular No.2021-015-A || Extension of FDA Circular No. 2021-015 entitled “Interim Guidelines on the Renewal of Current Good Manufacturing Practice (cGMP) Clearance of Foreign Drug Manufacturers”
In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular (FC) No. 2021-015 entitled “Interim Guidelines on the Renewal of Current Good Manufacturing […]
FDA Circular No.2021-011-A || Extension of Transitory Period and Provision of Interim Guidelines for Product Registration, including the Labeling Requirements, for Household Urban/Hazardous Substances
I. RATIONALE On 24 May 2021, the Food and Drug Administration (FDA) issued FDA Circular No. 2021-011 with subject, Extension of Transitory Period for the Implementation of FDA Circular No. […]