Regulatory Affairs CMC guidance documents to help prepare INDs

At the very first time, if any company is planning to apply for an IND and start planning internally, it starts with the a basic target product profile to begin with the development products.

Companies/professionals greatly underestimate the time to prepare and submit well-designed, well-executed IND. From the time it is decided, responsible departments focus mainly on a genuine clinical candidate and typically plan on at least a one or two-year time frame to gather sufficient information to file an IND and submit it to the FDA (Health authority).

Companies/Regulatory affairs (RA) professionals which devote methodical, systematic attention from day one would move far more efficiently toward clinical trials than companies who delay.

Ideally, even before the research phase, applicants/ RA professionals should start studying the relevant FDA requirements and form details for an IND submission to determine how best they can meet those requirements and achieve approval efficiently in less extent of time with least number of queries from HA.

For ease and quick reference to RA professionals, URRA CMC lists below the IND guidance with the complete details. The below guidance emphasizes mainly on CMC (Chemistry, manufacturing and controls) of the product to be filed.

CMC guidance documents to help prepare INDs

CFR - Code of Federal Regulations Title 21: The following regulations apply to the IND application process:

• 21CFR Part 201 - Drug Labeling

• 21CFR Part 312 - Investigational New Drug Application

• 21CFR Part 314 - INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval)

• 21CFR Part 316 - Orphan Drugs

• 21CFR Part 50 - Protection of Human Subjects

• 21CFR Part 54 - Financial Disclosure by Clinical Investigators

• 21CFR Part 56 - Institutional Review Boards

• 21CFR Part 58 - Good Lab Practice for Nonclinical Laboratory [Animal] Studies

CMC (Chemistry, manufacturing and controls) guidance

1. CDER MAPP 6030.1 – “IND Process and Review Procedures (Including Clinical Holds)”, 2011 - Link

2. 21 U.S.C. 353 – “Exemptions and Consideration for Certain Drugs, Devices, and Biological Products”, 2011 - Link

3. Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications – “Determining Whether Human Research Studies Can be Conducted Without an IND, September 2013” - Link

4. Draft Guidance for Industry: “Expanded Access to Investigational Drugs for Treatment Use---Q&A's”, 2017 - Link

5. Drug Development Approval Process, 2016 - Link

6. FDA Web site “Use of Drug Name Terms Policy”, 1996 - Link

7. Form 1571 Instructions, 2019 - Link

8. Frequently Asked Questions About Combination Products, 2019 - Link

9. Guidance for Industry: “Botanical Drug Development”, 2016 - Link

10. Guidance for Industry: “Content and Format of Investigational New Drug Applications (INDs) for Phase I Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products, November 1995, (IND Phase I Guidance)” - Link

11. Guidance for Industry: cGMP for Phase I Investigational Drugs, July 2008 - Link

12. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry, 2017 - Link

13. Guidance for Industry: INDs for Phase 2 and Phase 3 Studies, Chemistry, Manufacturing, and Controls Information, May 2003 at 23 (Resources indicates that while the ICH documents listed in this guidance as resources are not intended to be applicable to IND applications, they can serve as valuable resources in guiding the course of product development), 2003 - Link

14. Guidance for Industry: Investigators, and Reviewers: Exploratory IND Studies, January 2006 - Link

15. Guidance for Industry: The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use, 2016 - Link; Link

16. Investigational New Drug (IND) Application, 2020 - Link

17. New Drug, Antibiotic, and Biologic Drug Product Regulations, “IND Rewrite,” Final Rule, Dkt. No. 82N-0394, 52 Fed. Reg. 8798 (March 19, 1987) - Link

18. “Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products” - Questions and Answers, 2000 - Link

19. “Formal Meetings Between the FDA and Sponsor or Applicants of PDUFA products”, 2017 - Link

20. “IND meetings for human Drugs and Biologics-Chemistry, Manufacturing, and Controls information” , 2001 - Link

21. “Center for Biologics Evaluation and Research (CBER) responsibilities” - Questions and Answers, 2018 - Link

22. “Drug Master Files: Guidelines”, 1989 - Link

Additional: Guidance documents required for IND preparation

1. “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations”, 2019 - Link

2. “Exploratory IND Studies”, 2006 - Link

3. “FDA IND, NDA, ANDA, or Drug Master File Binders”, 2016 - Link

4. “Immunotoxicology Evaluation of Investigational New Drugs”, 2002 - Link

5. “IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer”, 2004 - Link

6. “Safety Assessment for IND Safety Reporting Guidance for Industry”, 2015 - Link

7. “Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies”, 2012 - Link

8. “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations”, 2019 - Link