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A notice of proposed rulemaking (NPRM) is a public notice that is issued by law when a U.S. federal agency wishes to add, remove, or change a rule or regulation as part of the rulemaking process.
An investor might be seeking more favourable terms under the contract or might need the side letter to enter the venture under terms to meet regulatory requirements. [ 3 ] In Barbudev v Eurocom Cable Management Bulgaria Eood and others (2011), the High Court decided that a side letter provided an opportunity to invest on terms to be agreed, and ...
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
A special example of a press release is a communiqué [1] (/ k ə ˈ m juː n ɪ k eɪ /; French:), which is a brief report or statement released by a public agency. A communiqué is typically issued after a high-level meeting of international leaders.
The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject. You may improve this article , discuss the issue on the talk page , or create a new article , as appropriate.
The Regulatory News Service (RNS) is a British filing service that collects and transmits regulatory and non-regulatory information published by public companies to investors. This allows public companies to comply with ongoing disclosure or continues disclosure requirements.
The financial, research, and pharmaceutical regulatory structures in one country, for example, may be similar but with particularly different nuances in another country. These similarities and differences are often a product "of reactions to the changing objectives and requirements in different countries, industries, and policy contexts". [7]
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.