FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) submissions and decrease the number of assessment cycles needed for approval. The following topics highlight FDA’s current thinking and recommendations to avoid common deficiencies found in ANDA submissions and is not meant to be a comprehensive list. FDA has published guidance on many of these topics. Guidances referenced in the following sections are supportive and not a complete list. To find a guidance related to drugs, visit Guidances for Drugs.
Webinars and Other Resources for Industry
(Topics arranged alphabetically)
Bioequivalence
An ANDA submission must demonstrate that the proposed generic drug product is bioequivalent to the Reference Listed Drug (RLD). The requirements for bioequivalence (BE) are set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. FDA has several Guidances and Draft Guidances for Industry that shares the Agency’s current thinking on bioequivalence studies. The “Bioequivalence Recommendations for Specific Products Final Guidance,” (June 2010), provides recommendations to applicants planning to include BE information in ANDAs and ANDA supplements. The guidance describes how to meet the BE requirements set forth in FDA regulations.
In this section, we provide webinars on the different approaches and associated considerations for demonstrating BE. If you need specific information regarding FDA's current BE recommendations for a particular product, please refer to the relevant Product-Specific Guidance (PSG).
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Small Business and Industry Assistance - Advancing Generic Drug Development: Translating Science to Approval 2024, September 24-25, 2024
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Session 3 within this workshop includes three relevant presentations:
- Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence (BE) Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhalers
- Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches
- OPQR Testing & Research to Support Guidance Development of Inhalation Products
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Session 3 within this workshop includes three relevant presentations:
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Small Business and Industry Assistance - Advancing Generic Drug Development: Translating Science to Approval 2023, September 13-14, 2023
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Session 2 within this workshop includes the following relevant presentations:
- Complex Nasal Suspension PSG: Utilization of Newly Recommended In Vitro Only Bioequivalence Option
- Complex Nasal Suspension: Utilization of In Silico PK Studies to Support Development and Approval
- Loxapine Inhalation Powder: OTR Research Conducted to Inform the PSG Recommendations
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Session 5 of this workshop is composed of four sessions:
- Innovative Technology: Particle Image Velocimetry (PIV) and High-Speed Imaging to Support Approval of Generic Orally Inhaled Drug Products
- First Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Bioequivalence Perspective
- First Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Quality Perspective
- Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder
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Session 2 within this workshop includes the following relevant presentations:
Communication with FDA: Pathways and Best Practices
Communication between FDA and prospective applicants and applicants during generic drug development may facilitate earlier availability of safe and effective drugs to the American public. The FDA provides several channels for communication to assist prospective applicants and applicants in developing more complete ANDA submissions, which results in greater efficiency of the drug development process and more efficient and robust development programs. The webinars below provide information to prospective applicants and applicants on how to efficiently conduct interactions with the FDA .
Comparative Analysis for Drug-Device Combination Products
The Draft Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry, and the webinars below, provide recommendations for proposed combination products that includes both a drug constituent part and a delivery device constituent part.
Data Integrity
FDA expects that all data be reliable and accurate. Current good manufacturing practice (CGMP) regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Generic drug manufacturers should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. For more clarity on the role of data integrity in CGMP for drugs, refer to the final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance and the webinars referenced below were developed in response to an increase in findings of data integrity lapses in recent inspections.
Labeling
Generic drug labeling [labeling under an abbreviated new drug application (ANDA)] generally must be the “same as” the reference listed drug (RLD) labeling except for permissible differences (e.g., manufacturer/packer/distributor information, package size, inactive ingredients, omission of information protected by patent or exclusivity, differences due to an approved suitability petition). The guidance entitled, “Good ANDA Submission Practices Guidance for Industry” and the webinars referenced below highlight common labeling deficiencies and recommendations to applicants on how to avoid these deficiencies.
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ANDA Labeling: Helpful Hints and Resources, April 28, 2021
FDA discusses an overview of the labeling review process, helpful hints, and challenge questions. -
Common Labeling Deficiencies and Tips for Generic Drug Applications, May 7, 2021
This webinar provides an overview of frequently asked labeling questions from ANDA applicants and most common labeling deficiencies and how to avoid them. -
Generic Drug Labeling: Recommendations for High-Quality Submissions, April 15, 2020
This webinar provides an explanation of the labeling review process, responses to frequently asked questions by industry, and recommend useful recommendations to provide high-quality labeling submissions and reduce review cycles. -
Generic Drugs – Specific Labeling Resources for Industry
This link provides resources for generic drug-specific labeling legislation/regulations, Generic drug-specific labeling guidances and MAPP, as well as other generic drug-specific labeling resources.
Pharmacology/Toxicology
Generic drugs must have the same safety profile as the RLD. This is determined through safety assessments on impurities and excipients in generic drug products for dosage, duration of exposure, patient population, and route of administration. This section includes webinars on common deficiencies related to impurities, excipients, residual solvents, and contaminants from container closures.
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Excipient Safety Assessment in Generic Drug Formulations: An Overview, December 6, 2022
This webinar provides an overview of the regulatory framework for formulation sameness assessment related to (1) qualitative (Q1) and quantitative (Q2) formulation sameness, and (2) “no significant difference” assessments, the considerations for inactive ingredient levels in a formulation and the use of inactive ingredient database and identifying considerations and potential challenges during formulation development. -
FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs, November 2022
This webinar discusses comparative clinical studies and other assessments used to evaluate the bioequivalence and comparative safety of new potential generic drug products. Scenarios and review the methods used by FDA to monitor the safety and effectiveness of generic drugs in the pre-market and post-market setting related to assessing the safety of excipients in generic drug products, including describing the sources of drug impurities. -
Safety Evaluation of Drug Substances: Impurities in Generics, March 4, 2021
This webinar provides the key aspects of the safety assessment of drug substance impurities in generic drug products, OGD-Pharmacology/Toxicology review process for drug substance impurities, and case studies highlighting key aspects and common pitfalls in safety evaluation of drug substance impurities in generic drug products. -
Local Toxicity of Considerations for Qualifying Excipients in Generic Drugs, September 29, 2020
This webinar introduces the concept of local safety assessment of excipients in generic drugs, key aspects of excipient local safety review, and demonstrates how safely information, data gaps, and content of use impact recommendations.
Product-Specific Guidances
To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs. For more information, visit Product-Specific Guidances for Generic Drug Development to search for specific PSGs.
Quality
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Office of Pharmaceutical Quality (OPQ) ensures a uniform drug quality program across all sites of manufacture and has shared helpful information in Pharmaceutical Quality Resources. These resources offer information on pharmaceutical quality topics for manufacturers and applicants including chemistry, manufacturing, and controls information for NDAs, ANDAs, BLAs, and IND applications. There is information on Current Good Manufacturing Practice CGMP Regulations for drug product manufacturing, processing, and packing. Additionally, there is information on advancing product quality in efforts to encourage innovation in manufacturing processes and technology.
Risk Evaluation Mitigation Strategy
Risk Evaluation and Mitigation Strategies (REMS) are drug safety programs that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
