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The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
Renewal Employment Authorization Document: the renewal process takes the same amount of time as a first-time application so the noncitizen may have to plan ahead and request the renewal 3 to 4 months before expiration date. Replacement Employment Authorization Document: Replaces a lost, stolen, or mutilated EAD. A replacement Employment ...
Form I-129 is used to either file for a new status or a change of status, such as new, continuing or changed employer or title; or an amendment to the original application. Approval of the form makes the worker eligible to start or continue working at the job (on or after the indicated start date) if already in the United States. If the worker ...
A 2002 U.S. Government Accountability Office (GAO) report found that PDUFA funds allowed the FDA to increase the number of new drug reviewers by 77 percent in the first eight years of the act, and the median approval time for non-priority new drugs dropped from 27 months to 14 months over the same period.
Labor Condition Application. The Labor Condition Application (LCA) is an application filed by prospective employers on behalf of workers applying for work authorization for the non-immigrant statuses H-1B, H-1B1 (a variant of H-1B for people from Singapore and Chile) and E-3 (a variant of H-1B for workers from Australia).
A unilateral NDA (sometimes referred to as a one-way NDA) involves two parties where only one party (i.e., the disclosing party) anticipates disclosing certain information to the other party (i.e., the receiving party) and requires that the information be protected from further disclosure for some reason (e.g., maintaining the secrecy necessary to satisfy patent laws [5] or legal protection ...
Non-solicitation agreement provisions—alongside the non-compete clause (NCC) and the non-disclosure agreement (NDA)—constitute one of three restrictive covenants frequently found within a business contract. They may be entered into with both employees and independent contractors—in addition to multiple entities—as part of a larger ...