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Table of Contents Chapter
1: From Principle to Practice Chapter
2: The Food and Drug Administration (FDA) Chapter 3: Title 21 of the Code of Federal Regulations (21 CFR) Chapter 4: Selected Acts & Authorizations Chapter 5: FDA Authority and Promotional Materials
Chapter 6: Selected FDA Forms
Chapter 7: Strategic Planning
for FDA Meetings Chapter
8: FDA Letters Chapter
9: Investigational New Drug (IND) with your ‘Study Drug’ Chapter 10: Investigational New Drug (IND) with your “Study Biologic” Chapter 11: New Drug Applications (NDA) Chapter 12: Biologics License Application (BLA)
Chapter 13: Abbreviated New
Drug Application (ANDA) Chapter
14: Over-The-Counter (OTC) Drug Products Chapter
15: 510(k) Premarket Notification Chapter
16: Investigational Device Exemption (IDE) Chapter 17: Premarket Approval (PMA) Chapter 18: Humanitarian Use Devices (HUD) Chapter 19: Humanitarian Device Exemption (HDE) Chapter 20: In Vitro Diagnostic (IVD) Chapter 21: Center for Veterinary Medicine (CVM) Chapter 22: Center for Food Safety and Applied Nutrition (CFSAN) Chapter 23: Cosmetics Chapter 24: US and Global Acronyms that you May Encounter Chapter
24: US and Global Acronyms that you May Encounter A Look Inside The Book - Sample From Page 244 GCP
... Good Clinical Practice GCLP
... Good Control Laboratory Practice GDP ... Good Distribution Practice GLP ... Good Laboratory Practice (Safety/Toxicology studies) GMP ... Good Manufacturing Practice GxP ... Good x' Practice = GMP, GAMP, GCLP,
etc. GRAS ...
Generally Recognized as Safe (USA) GRASE
... Generally Recognized as Safe and Effective (USA) GRP ... Good Regulatory Practice GSL ... General Sales List (UK) HACCP ... Hazard Analysis and Critical Control Points (a Risk Analysis technique) HCPCS ... Healthcare Common procedure Coding
System is a set of health care procedure codes based on the AMA CPT HPB ... Health Protection Branch (Canada) - now Health Canada HVAC ... Heating Ventilation and Air Conditioning Hx ... History IAG ... Inspection Action Group (UK MHRA)
ICD-9 Codes ...
International Classification of Diseases (ICD)
... is the International Statistical Classification
of Diseases and Related Health Problems; ninth revision ICD-10 Codes ... International Classification of Diseases (ICD) is the International
Statistical Classification of Diseases and Related Health Problems; tenth revision ICH ... International Conference on Harmonization (EU,
Japan, IDE ...
Investigational Device Exemption (see FDA websites for IFPMA ... International Federation of Pharmaceutical Manufacturers Associations IKS ... Switzerland Regulatory Authority IMB ... Irish Medicines Board IMP ... Investigational Medicinal Product (Clinical Trial
Product - EU terminology for a CT drug product) IMPD ... Investigational Medicinal Product Dossier (a sub-set of an EU CTA - Clinical Trial Application) IMP-MLA ... Manufacturing License Approval - Investigational
Medicinal Products INCI
... International Nomenclature of Cosmetic Ingredients IND ... Investigational New Drug (USA) INN ... International Non-proprietary Name IP ... Intellectual Property IPCs ... In Process Controls IQ ... Installation Qualification
IQA ...
Institute of Quality Assurance (UK) ISPE
... International Society of Pharmaceutical Engineers ISO ... International Standards Organization ISO Certification ... An ISO certification is required
for shipping 510(k) devices to ensure that their quality system
is specifically developed for the handling of devices, test kits and the like to ensure no tampering. IUPAC ... International Union of Pure
and Applied Chemistry IV/IVTC
... In-vivo/in-vitro correlation IVDD ... In vitro Diagnostic Medical Devices Directive IWG ... Inspectorate Working Group (EU) JAN ... Japanese Approved Name JNDA ... Japanese New Drug Application
JP ...
Japanese Pharmacopoeia JPMA
... Japanese Pharmaceutical Manufacturers Association LAF ... Laminar Air Flow LOD ... Limit of Detection LOQ ... Limit of Quantization (quantitation) Chapter 8: FDA Letters A Look
Inside The Book - Sample From Page 36 8.1 FDA Enforcement Letters The FDA writes violative letters to sponsors, manufacturers or stakeholders
for violating the regulations. These letters are to be taken seriously and have an associated time limit for actions and/or
responses with the FDA. The
Division of Drug Marketing, Advertising and Communications (DDMAC) finds advertising or promotion to be violative, agency
has administrative and judicial tools for dealing with violations denoted as NOV/Untitled Letters, Warning letters, ordering
a recall, calling for the delay, suspension or withdrawal of a product approval. The most common violative letters are Untitled/NOVs
and Warning Letters. Form
FDA 482 ... The Form FDA 482 is a pre-approval inspection notice. The are coming to inspect you. Form FDA 483 ... (15d) Form FDA 483 (“Notice of Inspectional
Observations”) ---- Reported deficiencies
found during the inspection and reported to the manufacturer the warning letter is sent to an inspected company
indicating that higher level FDA officials have reviewed the inspection findings and that the findings warrant further
formal notification to the inspected company that serious violations may exist. ---- The recipient of the FDA 483 has 15 business days to respond to the
FDA to either provide a timeline for correction or request clarification of what the FDA requires. ---- Form 483 is issued by the inspector at the facility before departure.
This is a good time to ask questions. The form contains only those observations that can be directly linked to a violation
of regulations. No suggestions, comments or guidance are contained on the form only the observations or opinions from the
inspector that may be reviewed by additional staff at the FDA. ---- A follow-up letter is required per FDA policy which is sent back to the clinical investigators and IRBs.
Upon further review of the 483 within the FDA, the FDA is not restricted to the on-site observations and these issues will
be added to the follow-up letter. ----
NIDPOE This is a Notice of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE). They are intended
administrative proceedings.
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