SCOPE AND COVERAGE
This Circular shall cover all stakeholders applying for FDA Authorizations and other stakeholders who are required to submit documents, scheduled to appear at FDA for compliance/meetings, and/or pay appropriate fees and charges.
Likewise covered by this Circular is the commencement of administrative actions including administrative cases pending evaluation. proceedings, or for decisions involving violations of R.A No. 3720, as amended by R.A. No. 9711 and other FDA-implemented laws, rules and regulations.
This Circular does not cover the proceedings and running of reglementary periods for urgent cases which are necessary to enable the FDA to act expeditiously on matters affecting the current public health emergency, such as any coronavirus disease 2019 (COVID-19) related cases (e.g. violations of the imposed price freeze or ceiling on covered products or those cases pertaining to activities or products regulated by FDA without prior authorization intended for or claiming to address the COVID-19)
For purposes of these Guidelines, community quarantine shall mean the Enhanced Community Quarantine, the General Community Quarantine, and local community quarantines declared in accordance with IATF Guidelines.
to continue reading,click HERE–>FDA Circular No.2020-006-B
SEE ALSO: FDA Circular No. 2020-006
SEE ALSO: FDA Circular No. 2020-006-A