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The following is a summary description of the types of applications and submissions:
Original applications are generally submitted for new products or for new uses of food and color additives or for new food labeling claims.
Investigational new drug application (IND)--for drugs and biologics
New drug application (NDA)--human drug
Product license application (PLA)--biologics
Establishment license application (ELA)--biologics
Biologics license application (BLA)--combines PLA and ELA for biologics
Premarket application (PMA)--medical device
Food additive petition (FAP)
Color additive petition (CAP)
New animal drug application (NADA)
Nutrient Content Claim Petitions
Health Claim Petitions
510(k) applications (premarket notifications) are submitted to establish that a medical device is "substantially equivalent" to an already marketed device.
Generic drug applications generally are submitted to establish that a firm can manufacture a copy of a brand name drug.
Abbreviated new drug application (ANDA)
Abbreviated antibiotic drug application (AADA)
Abbreviated new animal drug application (ANADA)
Supplemental applications generally are submitted for changes in already approved products, including the addition of a new indication or changes in how a product is manufactured.
Efficacy supplements
Manufacturing supplements
Labeling supplements
Chemistry supplements
Other supplements
Other applications and submissions include investigational applications, fast track designation requests, notifications, and petitions.
| Time Frame | Relevant Statute | FY 1999 Performance Plan Goal--Percentage of First Actions Within Time Frame | FY 1997 Baseline (Estimate)--Percentage of First Actions Within Time Frame | Number Overdue as of 9/30/98 |
|---|---|---|---|---|
| Review Priority NDAs within 6 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) |
90 percent | 100 percent | 0 |
| Review Standard NDAs within 12 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) |
90 percent | 99 percent | 0 |
| Review Standard NDAs within 10 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) |
30 percent | N/A | N/A |
| Review Priority NDAs/PLAs/BLAs within 6 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs. |
90 percent | 100 percent | 0 |
| Review Standard NDAs/PLAs/BLAs within 12 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs. |
90 percent | 100 percent | 0 |
| Review Standard NDAs/PLAs/BLAs within 10 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs. |
30 percent | N/A | N/A |
| Review priority efficacy supplements within 6 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. |
90 percent | 100 percent | 0 |
| Review standard efficacy supplements within 12 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. |
90 percent | 100 percent | 2 |
| Review standard efficacy supplements within 10 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. |
30 percent | N/A | N/A |
| Review priority efficacy supplements within 6 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements. |
90 percent | 100 percent | 0 |
| Review standard efficacy supplements within 12 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements. |
90 percent | 100 percent | 0 |
| Review standard efficacy supplements within 10 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements. |
30 percent | N/A | N/A |
| Review manufacturing supplements within 6 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. |
90 percent | 98 percent | 21 |
| Review manufacturing supplements within 4 months. (CDER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. |
30 percent | N/A | N/A |
| Review manufacturing supplements within 6 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements. |
90 percent | 98 percent | 6 |
| Review manufacturing supplements within 4 months. (CBER) | Section 101(4) of FDAMA. FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements. |
30 percent | N/A | N/A |
| Time Frame | Relevant Statute | FY 1999 Performance Plan Goal--Percentage of First Actions Within Time Frame | FY 1997 Baseline (Estimate)--Percentage of First Actions Within Time Frame | Number Overdue as of 9/30/98 |
|---|---|---|---|---|
| Review ANDAs within 180 days. (CDER) | FD&C Act Sec. 505(j) | 60 percent | 54 percent | 142 |
| Review Blood PLAs/BLAs within 12 months. (Internal time frame) (CBER) | None | 70 percent | 83 percent | 4 |
| Review Blood PLA/BLA major supplements within 12 months. (Internal time frame) (CBER) | None | 70 percent | N/A | 0 |
| Review Blood ELA major supplements within 12 months. (Internal time frame) (CBER) | None | 60 percent | 98 percent | 9 |
| Review PMAs within 180 days. (CDRH) | FD&C Act Sec. 515(d)(1)(A) | 50 percent | 65 percent | 0 |
| Review PMA supplements within 180 days. (CDRH) | FD&C Act Sec. 515(d)(6) | None | 65 percent | 0 |
| Review 510(k)s within 90 days. (CDRH) | FD&C Act Sec. 510(k) | 90 percent | 98 percent | 0 |
| Review Food and color additive petitions within 360 days (CFSAN) Goals are based on 360 days. FY 1997 baseline based on 180 days (statutory requirement).** | FD&C Act Sec. 409 & Sec. 721 | 30 percent | 24 percent (within 180 days)** | 52 |
| Review NADAs & ANADAs within 180 days. (CVM) | FD&C Act Sec. 512(c)(1) | None | 75 percent | 6 |
| Decide Fast Track Requests within 60 days. (CDER and CBER) | Section 112, FDAMA | None | N/A | 1 |
| Review export applications for drugs and biologics within 30 days. | FD&C Act Sec. 801(e) & Sec. 802 | None | 100 percent | 0 |
| Complete processing of generally recognized as safe (GRAS) notifications within time frame of final rule. (CFSAN) | FD&C Act Sec. 409 & Sec. 721 | None | N/A | N/A |
| Review dietary ingredient notifications within 75 days. (CFSAN) | Dietary Supplement Health and Education Act, Sec.8 | None | 100 percent | 0 |
| Review infant formula notifications within 90 days. (CFSAN) | Infant Formula Act, Sec. 2 | None | 100 percent | 0 |
| Review health claim petitions within 100 days. (CFSAN) | Nutrition Labeling and Education Act, Sec. 3 | None | 100 percent | 0 |
| Review nutrient content claim petitions within 100 days. (CFSAN) | 21 USC 343(r) | None | 100 percent | 0 |
These performance levels are based on funding in the proposed budget and therefore
may change after the final budget is approved.
**For petitions received in FY 1996, using the previous petition review procedure, 24 percent of petitions received "first action" within 180 days. CFSAN re-engineered the petition review process in FY 1998 and redefined "first action." FY 1997 figures and FY 1999 and FY 2000 estimates are not directly comparable.
| CENTER(S) | |
|---|---|
| NDA Labeling Supplement | CDER, CBER |
| NDA Other Supplement | CDER, CBER |
| ANDA Efficacy Supplement | CDER, CBER |
| ANDA Manufacturing Supplement | CDER, CBER |
| ANDA Labeling Supplement | CDER, CBER |
| ANDA Other Supplement | CDER, CBER |
| Product License Application (PLA)/Biologics License Application (BLA) | CBER |
| PLA/BLA Labeling Supplement | CBER |
| PLA/BLA Other Supplement | CBER |
| Establishment Licensing Application (ELA) | CBER |
| ELA Manufacturing Supplement | CBER |
| ELA Other Supplement | CBER |
| Investigational New Drug Application (IND) | CDER, CBER |
| Investigational New Device Exemption (IDE) | CDRH, CBER |
| NADA Manufacturing Supplement | CVM |
| NADA Non-manufacturing Supplement | CVM |
| NADA Other Supplement | CVM |
| ANADA Supplements | CVM |
| Investigational New Animal Drug Application (INADA) | CVM |
| Abbreviated INADA | CVM |
| Medicated Feed Application | CVM |
| In Vivo Bioequivalence Waiver | CVM |
| Color Certification | CFSAN |
| Orphan Drug Designation | CDER |
| Methadone Treatment Program Application | CDER |
| Application for Variance Certificate for Products | CDRH |
| Exemptions for Products Intended for U.S. Government Use | CDRH |
| Small Business Notices | CFSAN |
| Adverse Drug Experience Reports | CDER |
| Export New Drug Application | CDER |
| Initial Report for Listed Electronic Products | CDRH |
| Report of Model Changes for Listed Electronic Products | CDRH |
| Annual Reports for Listed Electronic Products | CDRH |
| Certificates of Products for Export | CDRH |
| Drug Experience Report | CVM |
| Notification of Importation of INADA | CVM |
| Notification of Exportation of INADA | CVM |
| Low Acid and/or Acidified Canned Food Process Filing | CFSAN |
| Infant Formula Exemptions | CFSAN |
| Food Contact Substance Premarket Notification | CFSAN |
| Nutrient Content Claim Based on Authoritative Statement by Scientific Body of the U.S. Government | CFSAN |
| Health Claim Based on Authoritative Statement by Scientific Body of the U.S. Government | CFSAN |
| GRAS Notifications | CFSAN |
| Notification of Safety Assessment of Genetically Engineered Plants | CFSAN |
| Structure / Function Claims (Dietary Supplements) | CFSAN |
| Certificate of Free Sale | CDER |
| Insulin Certification | CDER |
| IND for Export | CDER |
| ANDA Suitability Petition | CBER |
| Lot Release Protocol | CBER |
| Certificate of Exportability | CBER |
| WHO Certificates | CBER |
| Certificates to Foreign Governments | CBER |
| Import-for-Export Requests | CBER |
| IND for Export (312 Program) Requests | CBER |
| Other Export Requests | CBER |
| Export Approval Request | CDRH |
| Plans for the Repair of Electronic Products | CDRH |
| Temporary Marketing Permits | CFSAN |
| Authorization to Use Edible Product from Animals Treatment with INADs | CVM |
| Application for Export of Unapproved Animal Drugs | CVM |
| Reclassification Petition | CDRH |
| Reference Amount (Serving Size) Petitions | CFSAN |
| Food Standard Petitions | CFSAN |
| Investigational Food Additive Petition | CVM |
| Investigational Food Additive Petition Supplements | CVM |
| Abbreviated New Animal Drug Suitability Petition | CVM |
| Food Additive Petition for Animal Food/Pet Food | CVM |
| Food Additive Petition for Animal Food/Pet Food Supplements | CVM |
| GRAS Petition Animal Feed/Pet Food | CVM |
| GRAS Petition Animal Feed/Pet Food Supplements | CVM |
| Drug Product Listings (OTC) | CDER |
| Drug Registration Submissions | CDER |
| Drug Product Listings (Prescription) | CDER |
| Threshold of Regulation Exemption Request | CFSAN |
| Request for Alternative Approach to Nutrition Labeling | CFSAN |