| Betterchem |
| [2007 Index Page] |
|
|
|
|
Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 60 - PATENT TERM RESTORATION
|
|||
| 60-1 | Scope. | ||
| 60-2 | Purpose. | ||
| 60-3 | Definitions. | ||
| 60-10 | FDA assistance on eligibility. | ||
| 60-20 | FDA action on regulatory review period determinations. | ||
| 60-22 | Regulatory review period determinations. | ||
| 60-24 | Revision of regulatory review period determinations. | ||
| 60-26 | Final action on regulatory review period determinations. | ||
| 60-28 | Time frame for determining regulatory review periods. | ||
| 60-30 | Filing, format, and content of petitions. | ||
| 60-32 | Applicant response to petition. | ||
| 60-34 | FDA action on petitions. | ||
| 60-36 | Standard of due diligence. | ||
| 60-40 | Request for hearing. | ||
| 60-42 | Notice of hearing. | ||
| 60-44 | Hearing procedures. | ||
| 60-46 | Administrative decision. | ||