FDA Pharmaceutical Regulations
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER).Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use.
Table of Contents
Best Practices
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Best Practices in Developing Proprietary Names for Human Prescription Drug Products | FDA | The FDA guidance was issued to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. | English | Complimentary |
| Data Integrity and Compliance With Drug CGMP Questions and Answers | FDA | The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics).This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. | English | Complimentary |
ANDA
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Referencing Approved Drug Products in ANDA Submissions | FDA | This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission. | English | Complimentary |
| Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA | FDA | This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. | English | Complimentary |
| ANDA Submissions —Content and Format (2018) | FDA | This 2018 guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). | English | Complimentary |
IND
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Investigational New Drug Applications (INDs) —Determining Whether Human Research Studies Can Be Conducted Without an IND | FDA | .This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). | English | Complimentary |
| Bioavailability Studies Submitted in NDAs or INDs — General Considerations (2019) | FDA | This (2019) draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. | English | Complimentary |
GRP White Paper: FDA 5050(B)(2) Regulatory Pathway (NDA)
Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosmetic Act, the 505(b)(2) pathway expressly permits the US Food and Drug Administration (FDA) to rely, for approval of New Drug Applications (NDAs), on data not developed by the applicant.