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17/03/2022

***FDA Advisory No.2022-0591***

In the interest of service, the FDA informs all establishments and stakeholders that the Center for Drug Regulation and Research (CDRR) regulates the manufacture, importation, exportation, distribution sale, offer for sale, transfer, promotion, advertisement, sponsorship of veterinary medicine, vaccines and biologicals pursuant Book I, Article VII Sec. 8 of the rules and regulations implementing RA No. 9711 - The Food and Drug Administration Act of 2009. In addition, other veterinary products and medical devices shall from hereon be handled exclusively by the CDRR.

Read more:->https://bit.ly/3KUn8uv

15/03/2022

***Press Statement || FDA Philippines Grants Emergency Use Authorization of CoronaVac (Sinovac) for Pediatric Group***

On 11 March 2022, the Food and Drug Administration (FDA) granted the Emergency Use Authorization (EUA) of CoronaVac Vaccine, manufactured by Sinovac Life Sciences, for the prevention of COVID-19 in 6 to 17 years old individuals. The FDA recommends the vaccine for use in individuals 6 years of age and above in a two-dose schedule with 4 weeks spacing

CoronaVac is the third vaccine authorized by the FDA against COVID-19 for the pediatric age group in addition to the two mRNA vaccines manufactured by Pfizer (age 5 to 17 years old) and Moderna (age 12 to 17 years old). CoronaVac is an inactivated vaccine, which is stable in conditions requiring refrigerator temperature of 2 to 8 degrees Celsius.

Read more:->https://bit.ly/3i8sMNC

03/01/2022

JUST IN | Food and Drug Administration Director-General Dr. Eric Domingo, nagbitiw sa pwesto epektibo ngayong Lunes, January 3. | via Racquel Bayan

15/12/2021

***FDA Circular No.2021-026***

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 ASEAN Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents through Administrative Orders No. 2005-0015 and 2005-0025, respectively. The harmonization scheme involves the conduct of alignment meetings for the purpose of eliminating trade barriers and enhancing cooperation within the ASEAN Member States (AMS) in ensuring the safety, quality and claimed benefits of cosmetic products.

Read more:->https://bit.ly/325iMQo

10/12/2021

***FDA Circular No.2021-0025***

I. BACKGROUND

The Food and Drug Administration (FDA) issued FDA Circular (FC) No. 2020-024 on 20 August 2020 to provide updated guidelines for the application of FDA Authorizations amidst the Coronavirus Disease 2019 (COVID-19) pandemic and congruent with Presidential Proclamation No. 9221 dated 08 March 2020.

Further amendments to FC No. 2020-024 were issued to extend the validity of certain FDA authorizations expiring from 01 January 2021 in view of the interim changes and restrictions brought about by the pandemic in the FDA and its regulated entities. The extension of regulatory flexibilities is timely as it addresses the continuing impact of COVID-19 disease in the Philippines.

Whereas, on 10 September 2021, Proclamation No. 12182 was issued further extending the period of a state of calamity for a period of one (1) year, effective 13 September 2021 to 12 September 2022, unless earlier lifted or extended as circumstances may warrant.

In the interest of the service, this FDA Circular is hereby issued to reinforce the guidelines and ensure the continuity of services while protecting the internal and external stakeholders of the FDA.

Read more:->https://bit.ly/31JSTWn

18/11/2021

***FDA Advisory No.2021-2903***

This is in relation to the Department of Information and Communication Technology (DICT) Advisory dated 08 November 2021 on system maintenance entitled “Restoration of Government Common Platform (GCP) and New Cloud”. As part of the agency’s interim measures, the FDA Information and Communication Technology Management Division (ICTMD) established an interim application system to accept and facilitate applications for License-to-Operate. This system will be accessible on 22 November 2021 through https://eservices.fda.gov.ph.

Read more:->https://bit.ly/3HAH0lB

16/11/2021

18/10/2021

***FDA Advisory No.2021-2491***

The Center for Drug Regulation and Research (CDRR) of the Food and Drug Administration (FDA) will be conducting an inventory and processing of the pending applications for registration of drug products for human use. As such, the period 15 November 2021 to 15 January 2022 is hereby declared as an Application Holiday. This will enable the CDRR to catch-up with the backlog/pending applications and to conduct test-runs on the proposed systems to be implemented.

Read more:->https://bit.ly/3BU34V0

06/09/2021

***Draft for Comments || Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Registration (CPR) for Non-Medicated Veterinary Products/Cosmetics and Veterinary Medical Devices***

All comments can be sent at [email protected] . Deadline of submission of comments shall be by 16 September 2021 (Friday).

I. BACKGROUND

In accordance with the provisions of the Republic Act (RA) No. 3720, Subject: Food, Drug, and Cosmetic Act, as amended by Executive Order No. 175 and RA No. 9711, subject: Food and Drug Administration Act of 2009, the FDA is mandated to cover the regulation of manufacture, distribution, sale, offer for sale, and other regulated activities and monitoring of veterinary drugs and products, veterinary biological products, device and establishments.

Read more:-> https://bit.ly/3n55J9Q

02/09/2021

***FDA Advisory No.2021- 2223***

Under FDA Circular 2021-008 or the Updated Guidelines for the Registration of Drug Products Under Emergency Use (DEU) for COVID-19, licensed drug establishments intending to manufacture and import/ distribute drug products listed in the Philippine COVID-19 Living Recommendations may register as DEU provided that such drug products have a positive recommendation and a registered counterpart with the FDA at the time of the application.

Read more:->https://www.fda.gov.ph/wp-content/uploads/2021/09/FDA-Advisory-2021-2223.pdf