Resources

Resources

Regulatory Requirement for Dosage Forms

The FDA has specific requirements for various dosage forms to ensure their safety, efficacy, and quality. Here are some general FDA requirements for common dosage forms:

1 – Solids (Tablets, Capsules, etc.):

• Composition and active ingredients
• Manufacturing process and controls
• Stability and dissolution testing
• Labeling requirements

2 – Modified Release Dosage Forms (Extended Release, etc.):

• Release characteristics over time
• Bioavailability and bioequivalence testing
• Manufacturing process controls

3 – Injectables (Solutions, Lyophilized powder, etc.):

• Sterility and pyrogenicity testing
• Particle size and distribution
• Compatibility with delivery devices
• Container closure systems studies

4 – Inhalations (Metered Dose Inhalers, etc.):

• Particle size distribution
• Delivered dose uniformity
• Device performance testing
• Microbiological quality

5 – Semi-solids (Creams and Ointments):

• Active ingredient content and uniformity
• Microbiological quality
• Stability under various conditions
• Container integrity

6 – Solutions and Suspensions (Oral and Topical):

• Chemical and physical stability
• Homogeneity of active ingredients
• Particle size (for suspensions)
• Microbiological quality

These are general FDA requirements for common dosage forms. Specific regulations may vary depending on the dosage form and intended use. Manufacturers must ensure compliance with all applicable FDA regulations and guidelines for product approval.

If you’re considering submitting an ANDA, numerous resources are available to assist with your application and submission process. These resources are designed to guarantee that your ANDA submissions are thorough, precise, and compliant with all regulatory standards.

ANDA Forms & Submission Requirements: A comprehensive guide on the FDA’s website, offering detailed information on required forms and the submission process.

Electronic Submissions Gateway: The primary platform for submitting ANDA applications and other regulatory documents to the FDA.

Drug Information Portal: A resource for information on FDA-approved drugs, essential for gathering data on reference listed drugs.

Good ANDA Submission Practices: Offers insights into best practices for preparing and submitting applications.

Association for Accessible Medications (AAM): Provides educational resources, regulatory updates, and advocacy services for companies involved in generic drug development.

The Manual of Policies and Procedures (MAPPs) offers insights into the internal practices and procedures followed by CDER staff, standardizing the evaluation process for ANDA, NDA, and IND applications.