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2015 FDA Circular

7 issuances in 2015

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2015 FDA Circular Clear
  1. Jul 30, 2015 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
  2. Jun 24, 2015 FDA Circular No. 2015-11 GUIDELINES ON IMPLEMENTING FDA CIRCULAR NO. 2014- 011 ON ADOPTION OF UNIQUE GLOBAL PRODUCT IDENTIFICATION NUMBER FOR DRUG PRODUCTS
  3. Apr 13, 2015 FDA Circular No. 2015-006 NEW LTO FORMAT FOR DRUG ESTABLISHMENTS FOLLOWING ADMINISTRATIVE ORDER NO. 2014-0034
  4. Apr 10, 2015 FDA Circular No. 2015-007 RULES AND REGULATIONS ON THE LICENSING OF HOSPITALS AND OTHER HEALTH FACILITIES INVOLVED IN THE MANUFACTURE OF MEDICAL GASES
  5. Mar 6, 2015 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
  6. Feb 20, 2015 FDA Circular No. 2015-002 GUIDELINES ON THE ELECTRONIC NOTIFICATION OF TOYS AND CHILDCARE ARTICLES (TCCAS)
  7. Jan 21, 2015 FDA Circular No. 2015-001 CLARIFICATIONS ON THE REGULATIONS GOVERNING PRINCIPAL AND IDENTICAL DRUG PRODUCTS AS DEFINED UNDER ADMINISTRATIVE ORDER NO. 2005-0031