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Agency issuances
16,884 issuances · 1941–2026
67 issuances from the 2010s
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- FDA Circular No. 2015-012 ADDITIONAL REQUIREMENTS FOR THE EFFECTIVE IMPLEMENTATION OF FDA CIRCULAR NO. 2013-014, LIST OF PRODUCTS REQUIRING BIOEQUIVALENCE (BE) STUDIES AS PART OF THE APPLICATION FOR MARKETING AUTHORIZATION IN ADDITION TO RIFAMPICIN AND THE 11 PRODUCTS LISTED IN BUREAU CIRCULAR NO. 2006-008
- FDA Circular No. 2015-11 GUIDELINES ON IMPLEMENTING FDA CIRCULAR NO. 2014- 011 ON ADOPTION OF UNIQUE GLOBAL PRODUCT IDENTIFICATION NUMBER FOR DRUG PRODUCTS
- FDA Circular No. 2015-006 NEW LTO FORMAT FOR DRUG ESTABLISHMENTS FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034
- FDA Circular No. 2015-007 RULES AND REGULATIONS ON THE LICENSING OF HOSPITALS AND OTHER HEALTH FACILITIES INVOLVED IN THE MANUFACTURE OF MEDICAL GASES
- FDA Circular No. 2015-003 GUIDELINES ON THE IMPLEMENTATION OF NEW RULES AND REGULATIONS ON THE LICENSING OF SPONSORS AND CONTRACT RESEARCH ORGANIZATIONS (CROS) FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034, DATED 13 OCTOBER, 2014
- FDA Circular No. 2015-002 GUIDELINES ON THE ELECTRONIC NOTIFICATION OF TOYS AND CHILDCARE ARTICLES (TCCAS)
- FDA Circular No. 2015-001 CLARIFICATIONS ON THE REGULATIONS GOVERNING PRINCIPAL AND IDENTICAL DRUG PRODUCTS AS DEFINED UNDER ADMINISTRATIVE ORDER NO. 2005-0031
- FDA Circular No. 2014-028 GUIDELINES ON THE IMPLEMENTATION OF NEW RULES AND REGULATIONS ON THE LICENSING OF RETAIL OUTLET FOR NON- PRESCRIPTION DRUGS (RONPDS) FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034, DATED 13 OCTOBER 2014
- FDA Circular No. 2014-027 GUIDELINES ON THE IMPLEMENTATION OF NEW RULES AND REGULATIONS ON THE LICENSING OF DRUG MANUFACTURER FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034, DATED 13 OCTOBER 2014
- FDA Circular No. 2014-026 GUIDELINES ON THE IMPLEMENTATION OF NEW RULES AND REGULATIONS ON THE LICENSING OF DRUG DISTRIBUTORS FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034, DATED 13 OCTOBER 2014
- FDA Circular No. 2014-025 GUIDELINES ON THE IMPLEMENTATION OF NEW RULES AND REGULATIONS ON THE LICENSING OF DRUGSTORE/PHARMACY/BOTICA AND SIMILAR OUTLETS FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034, DATED 13 OCTOBER 2014
- FDA Circular No. 2014-014 MINIMUM NUMBER OF SAMPLE UNITS REQUIRED FOR EACH TEST ANALYSIS
- FDA Circular No. 2014-016 IMPLEMENTING GUIDELINES FOR ADMINISTRATIVE ORDER NO. 2013-0022 DATED 13 AUGUST 2013, SUBJECT: GUIDELINES FOR CURRENT GOOD MANUFACTURING PRACTICE (CGMP) CLEARANCE AND INSPECTION OF FOREIGN DRUG MANUFACTURERS
- FDA Circular No. 2014-013 RE-ASSESSMENT OF THE APPLICATION OF STEM CELL THERAPY FOR CORNEAL RESURFACING WITH LIMBAL STEM CELLS
- FDA Circular No. 2014-011 ADOPTION OF UNIQUE GLOBAL PRODUCT IDENTIFICATION NUMBER
- FDA Circular No. 2014-010 SALE AND DISTRIBUTION OF EMPTY GELATIN CAPSULES
- FDA Circular No. 2014-012 REQUIRING PROOF OF COURIER SERVICE PAYMENT FOR PROMOTION AND ADVERTISEMENT PERMITS
- FDA Circular No. 2014-009 FILING AND SUBMISSION OF APPLICATIONS FOR THE APPROVAL OF CLINICAL TRIAL PROTOCOL, COMPASSIONATE SPECIAL PERMIT (CSP), IMPORT PERMIT FOR INVESTIGATIONAL DRUG PRODUCTS, PHARMACOVIGILANCE, ADVERSE EVENTS/ADVERSE REACTION REPORTS, AND OTHER RELATED DOCUMENTS
- FDA Circular No. 2014-008
- FDA Circular No. 2014-007 ADOPTION OF THE KUALA LUMPUR PRINCIPLES DEVICE SECTOR CODE OF ETHICS
- FDA Circular No. 2014-006 APPLICATION FOR LTO VARIATION
- FDA Circular No. 2014-005 PROHIBITION OF THE OPERATION OF RADIOGRAPHIC X- RAY MACHINES WITH TUBE CURRENTS BELOW 100 mA IN DIAGNOSTIC RADIOLOGY
- FDA Circular No. 2014-004 EXTENSION OF SIX-MONTH MORATORIUM ON THE REQUIREMENT OF CERTIFICATE OF PRODUCT REGISTRATION FOR RAW MATERIALS TO BE PRESENTED TO THE BUREAU OF CUSTOMS (BOC) PRIOR TO RELEASE PER FDA MEMORANDUM CIRCULAR (FMC) NO. 2013-032 AND FMC NO. 2013-035 UNTIL 31 AUGUST 2014
- FDA Circular No. 2014-003 FILING AND RECEIVING OF REGISTRATION, LICENSING AND OTHER APPLICATIONS USING THE INTEGRATED APPLICATION FORM
- FDA Circular No. 2014-002 FILING OF APPLICATIONS FOR AUTHORIZATIONS BY REGION IV-A (CALABARZON) ESTABLISHMENTS IN FDA CENTRAL OFFICE