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However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise. [ 3 ] If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market ...
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
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 ...
The approval time for NDAs in the 8 years before the implementation of PDUFA I was roughly 31.3 months. During this period, the approval time exceeded 30 months in every year except 1990 when it was 27.7 months and 1992 when it was 29.9 months. From 1993 through 1996, the average approval time fell to 20.8 months.
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 ...
Form I-140 is a similar form filed by an employer or prospective employer for a worker for an employment-based visa (EB-1 visa, EB-2 visa or EB-3 visa). These employment-based visas are immigrant visas, and lead to Green Cards. The key difference between Forms I-140 and I-129 is that they are for immigrant and non-immigrant visas respectively.
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).
An automatic renewal clause is used in the insurance and healthcare industries . An automatic renewal clause (also referred to as an evergreen clause), is activated towards the end of the contractual period whereby it automatically renews the terms of an agreement except when the contract is terminated (through mutual agreement or contract breach), or one of the contracting parties has sent a ...