Label Regs Pharma Flashcards
Primary Purpose of Labeling
1.Provides clear and accurate information
2.Guides healthcare professionals and patients
Critical Role in Drug Safety and Efficacy
1.Ensures proper usage and dosage
2.Prevents adverse effects and misuse
Importance of Regulatory Compliance
1.Adheres to legal standards
2.Ensures patient safety
Maintaining Brand Integrity
1.Builds trust with consumers
2.Reflects commitment to quality
FDA’s Authority in Pharmaceutical Labeling
1.Has legal power to regulate drug labels
2.Ensures compliance with standards
FDA’s Role labeling
1.Reviews drug labels for approval
2.Ensures labels meet safety and efficacy standards
3.Oversees drug labeling to ensure accuracy
Protects consumers from misleading information
NDAs (New Drug Applications):
-NDAs are submitted to theU.S. Food and Drug -Administration (FDA)for the approval of new pharmaceutical drugs (including small molecule drugs).
-The CFRs governing NDAs are primarily found inTitle 21 of the Code of Federal Regulations (21 CFR).
These regulations cover various aspects related to drug development, clinical trials, labeling, manufacturing, and post-marketing surveillance.
Examples of topics covered in 21 CFR related to NDAs include:
Clinical trial requirements(e.g., design, conduct, and reporting)
Labeling requirements(e.g., content, format, and warnings)
Good Manufacturing Practices (GMP)for drug manufacturing facilities
Post-marketing safety reporting
Drug advertising and promotion
The FDA reviews NDAs to ensure that the drug is safe and effective for its intended use.
BLAs (Biologics License Applications):
BLAs are submitted for the approval ofbiological products, which include vaccines, blood products, gene therapies, and monoclonal antibodies.
The CFRs governing BLAs are primarily found inTitle 21 CFR Part 600.
These regulations specifically address the unique characteristics of biological products.
Examples of topics covered in 21 CFR Part 600 related to BLAs include:
Characterization of biological products
Comparability studies(for changes in manufacturing processes)
Product testing and release
Stability testing
Labeling requirements(specific to biologics)
The FDA reviews BLAs to ensure the safety, purity, and potency of biological products.
Overlap and Differences:
NDA Vs BLA
1.While there is some overlap between NDAs and BLAs (e.g., both involve preclinical and clinical data), the specific requirements and considerations differ due to the distinct nature of biological products.
2.BLAs often require more extensive characterization and comparability data because of the complexity of biologics.
3.The FDA evaluates BLAs based on thePublic Health Service Act (PHS Act)and its regulations.
Labeling Development Process
1.Proposal Phase -Developed by the drug company
2. Review Phase- Evaluated by FDA
3. Approval Phase -Final approval by the FDA
Features of Effective Labeling
- Clear and concise information
-Easy-to-read fonts and sizes
-Use of color coding for different types of medications
2.Easy to understand for patients
3.Proper placement on packaging
4.Compliance with regulatory standards
-Inclusion of necessary warnings and instructions
3 Different Types of Patient Labeling
Medication Guide (MG)
Patient Package Insert (PPI), also known as “Patient Information”
Instructions for Use (IFU)
Medication Guide (MG)
must be dispensed to the patient or caregiver in paper form, required by Agency for drugs with significant risk or safety
Patient Package Insert (PPI), also known as “Patient Information”
unless the product is contraceptives and estrogen containing products, distribution is not mandated. For those products that do not fall under those categories, FDA recommended a similar format for the MG and PPI so patients who see this, see similar information.
Instructions for Use (IFU)
detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal. The IFU is provided to patients (or their caregivers) when the drug is dispensed.
Carton and Container Labeling
Guidance focus:
1.Safety aspects of the design for the container label and carton labeling
2.Provides a set of principles and recommendations to ensuring critical elements are designed to promote
-Safe dispensing
-Safe administration
-Safe use of the product
