The US Food and Drug Administration (FDA) outlined the new and revised draft guidances that the agency plans to publish in 2018. Among the guidances it plans, the FDA’s Center for Drug Evaluation and Research (CDER) plans to publish guidances regarding pharmaceutical quality/chemistry, manufacturing, and controls (CMC), generic drugs, and user fees. Among its planned guidances, the Center for Biologics Evaluation and Research (CBER) plans to publish guidances relating to gene therapies.

CDER: Pharmaceutical quality/CMC

CDER plans to publish 13 guidances (new and revised draft guidances) in 2018 relating to pharmaceutical quality/CMC as outlined below:

• CDER’s Program for the Recognition of Voluntary Consensus Standards;
• Clarification of Human Drug Application Establishment Information Q&A Guidance;
• Drug Master Files; Revised Draft Version: 19 January 2018 Note: This guidance was first released in 1989 to provide guidelines for drug master files, which are used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs;
• Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process;
• Identification of Manufacturing Establishments in Applicants Submitted to CBER and CDER – Questions and Answers;
• In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products;
• Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft;
• Post-Approval Changes to Drug Substances (GDUFAII);
• Product Development and Quality Control of Transdermal and Related Delivery Systems;
• Quality Considerations for Continuous Manufacturing (CM);
• Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software;
• Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments;
• Using the Inactive Ingredient Database.

CDER: Guidances on generic drugs

CDER plans to publish 10 guidances (new and revised draft guidances) in 2018 relating to generic drugs as outlined below:

• 180-Day Exclusivity: Questions and Answers;
• Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft Note: The draft guidance, originally released in June 2016, is intended to provide recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal delivery system or a topical patch;
• Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs;
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft Note: The guidance, released in 2013, provides recommendations to applicants planning to include bioequivalence information in abbreviated new drug applications (ANDAs) and ANDA supplements;
• Failure to Timely Respond to an ANDA CR Letter;
• Referencing Approved Drug Products in ANDA Submissions; Revised Draft Note: The guidance, released in 2017, is intended to provide information to potential applicants on how to identify a reference listed drug, reference standard, and the basis of submission in an ANDA submission;
• Sameness Under the 505(j) Pathway;
• Therapeutic Equivalence – General Considerations;
• Three-Year Exclusivity Determinations for Drug Products;
• Variations in Drug Products (ANDAs) Guidance.

CDER: Guidances for user fees

CDER plans to publish two guidances (new and revised draft guidances) in 2018 relating to user fees as outlined below:

• Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products;
• Prescription Drug User Fee Act Waivers for Fixed Dose Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief.

CBER: Guidances on gene therapies

CBER plans to publish four guidances (new and revised draft guidances) in 2018 relating to gene therapies as outlined below:

• Testing of Retroviral Vector-Based Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Draft Guidance for Industry;
• Observing Subjects Who Received Human Gene Therapy Products for Delayed Adverse Events; Draft Guidance for Industry;
• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry;
• Gene Therapy for the Treatment of Hemophilia; Draft Guidance for Industry.

Additionally, in relation to gene therapy, CBER said it would publish new draft guidance for revised recommendations on reducing the risk of Zika virus transmission by blood and blood components as well as further testing of donations that are reactive on a screening test for antibodies for the hepatitis C virus.

Source: FDA (CDER) and FDA(CBER)