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FDA Approval for Drugs

FDA approval of a drug implies that the data on the drug's effects have been efficiently reviewed, and the drug is determined to offer benefits that are way more significant than its known or potential risks for the intended population.

*List of Forms and Requirements:

Form Requirements for Investigational New Drug (IND) Forms

  • FDA 1571 Investigational New Drug Application (Instructions for completing FDA forms 1571 and 1572)
  • FDA 1572 (pdf) Statement of Investigator (Instructions for completing FDA forms 1571 and 1572)
  • FDA Form Distributions Page Certification: Financial Interest and Arrangements of Clinical Investigators
  • Disclosure: Financial Interest and Arrangements of Clinical Investigators

Form Requirements for New Drug Application (NDA) Forms

  • Form FDA-356h (pdf) Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use
  • Form FDA-3397 (pdf) User Fee Cover Sheet
  • Form FDA-3331 (pdf) New Drug Application Field Report

Form Requirements for Abbreviated New Drug Application (ANDA) Forms, which are for Generic Production

  • Form FDA-356h (pdf) Application to Market a New Drug, Biologic or An Antibiotic Drug For Human Use
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations.  

*Kindly Note: The said forms may be found at: https://www.fda.gov/drugs/development-approval-process-drugs/forms-submission-requirements

1. IND Procedure

When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible (FDA Study Data Standards Resources).

Each application should be accompanied by:

While IND application sponsors are not required to submit information regarding clinical investigators' financial interests or arrangements in the original IND applications, they are expected to collect this information before a clinical investigator participates in a clinical study.

The current address for sending IND applications may be found at Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs). 

Upon receipt of an IND application, the FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.

An IND application may go into effect:

  • 30 days after FDA receives the application, unless the FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
  • On earlier notification by the FDA that the clinical investigations in the IND may begin. 

Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.

In addition to knowing the requirements for safety and other reporting, investigators submitting IND applications should be familiar with procedures about the following:

2. NDA Procedure

The goals of the NDA are to provide enough information for permitting the FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are as follows:

The NDA is the official request for the US approval of a drug. The NDA includes all animal and human data, plus side effects, dosing, and effectiveness. Other information, such as pharmacokinetics (how the drug moves through the body) and specifics of manufacturing, are also addressed.

  • The FDA team has 60 days to review the NDA and determine if it will be filed for further review.
  • Once an NDA is filed, the FDA reviews the product label (package insert) to ensure that the clinical information needed to use this drug safely is outlined. The FDA also takes action to inspect manufacturing plants where the drug will be made.
  • If the FDA finds the NDA insufficiently complete (reasons can vary from a simple administrative mistake in the application to a requirement to re-conduct testing), then the FDA rejects the application by sending the applicant a Refuse to File letter, which explains where the application failed to meet requirements.
  • Assuming the FDA finds everything acceptable, it decides if the NDA needs a standard or accelerated review and communicates acceptance of the application and its review choice in another communication, known as the 74-day letter.
  • A Standard Review implies an FDA decision within about ten (10) months, while a Priority Review should complete within six (06) months. The decision comes in a Complete Response Letter.

PDUFA: Some companies will pay for an expedited review with the FDA through a process known as PDUFA (Prescription Drug User Fee Act), enacted in 1992. PDUFA allows the FDA to access more resources to quicken the drug approval process. Many important drugs have been approved through PDUFA, including medicines for cancer, AIDS, and heart disease.

Accelerated Approval: The Accelerated Approval process began in 1992 to allow promising therapies for serious or life-threatening conditions for coming to the market more quickly. This method uses a 'surrogate endpoint' that predicts a reasonable clinical benefit of the drug. However, standard endpoints must still be proven after a drug is approved under post-marketing clinical trials to prove its benefit. If further post-marketing studies fail to verify the predicted clinical outcome, the FDA may withdraw approval.

Drugs that may be the first available treatment for an illness or with a significant benefit over existing drugs may receive a special designation:

  • Fast Track: Drugs that treat a serious medical condition and fill unmet medical needs may receive fast-track designation based on positive human or animal data. This FDA process, requested by the manufacturer, can get new drugs to patients who need them more quickly.
  • Breakthrough Therapy: Preliminary clinical research demonstrates that a drug candidate for a serious condition may provide a substantial improvement over available therapy. A drug designated for Breakthrough Therapy is also eligible for the Fast Track process. The sponsor must request this designation from the FDA.
  • Priority Review: During Priority Review, the FDA takes action on a new drug application within six (06) months, compared to ten (10) months under standard review. These drugs receive higher priority because they can significantly improve the treatment, diagnosis, or prevention of serious conditions.

FDA Advisory Board

A group of independent physicians and other clinicians, called an FDA Advisory Board, meets to discuss the NDA with the FDA reviewers and manufacturer of the product. These meetings often take one (01) or two (02) days. After the meeting, the Advisory Board makes a recommendation for approval, or not, to the FDA, usually through a vote. The FDA often follows the advice of the Board but is not obligated to do so. This advisory team includes physicians, pharmacists, chemists, pharmacologists, statisticians, and even patient representatives.

Final Drug Approval

After final approval, the drug becomes available for physicians to prescribe. However, the drugs may not come to the market immediately because of patent disputes, manufacturing issues, or controlled substance designation from the Drug Enforcement Administration (DEA). Pricing is usually revealed after approval, but the FDA does not consider drug pricing or economics as part of the FDA approval process. It is in contrast to many other countries that consider the economic impact of new drugs in their society.

3. ANDA Procedure

  • The ANDA is submitted to the FDA's Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the American public.
  • Electronic submissions of ANDAs are preferred.
  • A company that intends to market a generic drug needs to show the FDA that the drug is bioequivalent, which means that it can reach the part of the body where the drug works at the same time and in the same amount as the brand-name drug. This qualification is achieved by testing the generic version of the drug against the brand-name version on a small group of test subjects.
  • The statistical analysis of the test samples must show that there is no significant difference between the generic drug and the brand-name drug. 
  • The specific requirements are as follows:

1. Signed FDA form 356h.
It provides information regarding the applicant's name & address, name of the drug product, the product strength & route of administration, indication of drug master files cited, proposed indications, and a statement regarding whether the product is for prescription or over the counter.

2. An index should specify volume & page number for each complete and detailed item.

3. Information on the basis for which the ANDA is being submitted:

a) Name of the reference drug, its dosage form & strength.

b) Information exclusively on the listed drug

c) If a suitability petition is approved, a reference to the FDA number that was assigned to that suitability petition.

4. Condition for use, including,

a) A statement regarding the condition for which the drug will be used; and 

b) A reference to the annotated labeling for the product and the currently approved labeling for the listed drug product.

5. A statement that active ingredient is the same as for that of the reference drug. For the combination product, this must be shown for both active ingredients.

6. Route of Administration, Dosage Form, and Strength - It should include a statement that the route of administration, dosage form, and strength are the same as the reference drug.

7. Bioequivalence - It should include information to demonstrate that the proposed drug is bioequivalent to the listed drug product.

8. Labelling – It should include a copy of the currently approved labeling for the listed drug as well as the proposed labeling for the drug being provided for in the ANDA. A side by side comparison of two sets of labeling is also necessary.

9. Chemistry, Manufacturing, and Controls - It should describe the composition, manufacture, specifications, and analytical procedures for the drug substance and drug product.

10. Human Pharmacokinetics & Bioavailability - It includes information concerning:

a) The design 

b) The dosing procedure 

c) The number & frequency of blood and urine collection and methodology for the assay

11. Samples: The sample of the drug substance & finished product should be provided in four individual units with sufficient quantities in each unit to permit the FDA to perform all the tests included in the specifications at least three times.

12. The analytical method for drug substance and drug product: It should consist of the specifications, analytical method, certificates of analysis, method of analysis, method validation, and stability, indicating data is contained in the chemistry, manufacturing, and control part of the application.

13. Labeling: Specimen of the final printed label and all labeling for the drug product are to be included.

14. Case report forms & tabulations. The need for these should be discussed with appropriate personnel of the division of bioequivalence before submission of the ANDA.

Acceptability and Completeness

1. An application must contain sufficient information to allow a review to be conducted in an efficient and timely manner.

2. Upon receipt of the application, a pre-filling assessment of its completeness and acceptability is performed by a project manager within the regulatory support branch, Office of Generic Drugs.

3. If this initial review documents that the applicant contains all the necessary components, an 'acknowledgment letter' is sent to the applicant.

Refusal to File Letter Issued

1. If the application is missing one or more essential components, a 'Refuse to File' letter is sent to the applicant.

2. No further review of the application occurs until the applicant provides the requested data, and the application is found acceptable and complete.

3. If an ANDA is approved, the generic drug will be listed in the Orange Book, which lists all medicines the FDA has found to be safe, effective, and low-cost alternatives for the public.

4. If the approval occurs before the expiration of any patents or exclusivities accorded to the reference listed drug product, a tentative approval letter is issued to the applicant, which details the circumstances associated with the tentative approval of the generic drug product and delays approval until all patent/exclusivity issues have expired. A tentative approval does not allow the applicant to market the generic drug product.

*Cost of FDA Approval for Drugs:

USD 649/Drug

*Mode of Filing:

Online

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