Entities filing

BASIC at Dartmouth, features had been added for dealing with strings, arrays as entities, files, and overlays. 

The U.S. Eood and Dmg Administration (EDA) approved 22 new dmgs and one biotech medicine during 1994. These new dmg entities had an adjusted average review time of 19.7 months, from filing of the New Dmg AppHcation (NDA) at the EDA to time of approval. This was down from the 25.6 months for the 26 new entities approval in 1993. In the total dmg development and approval process it takes approximately 12 years for an experimental... 

To receive a filing date, an appHcation made on the basis of intent-to-use must include "a claim of bona fide intention to use the mark in commerce," a description of the goods upon or in connection with which the appHcant has the intention to use the mark and the mode and manner in which it is to be used, and a statement that the appHcant is entitled to use the mark and that, to the best of the appHcant s knowledge, no other person or entity has the right to use the mark or a confusingly similar mark. A drawing of the mark must be submitted with the appHcation. 

Clinical trial data that is not sent to the FDA can be exported from SAS in many ways other than SAS XPORT format files or ODM XML. This section discusses the numerous ways to export data from SAS to entities other than the FDA. 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

The filing of a full IND, with a formal coordinated writeup of all the supporting data, while necessary 40 years ago, is now an unnecessary requirement in the early-stage clinical programs of most large pharmas and CROs that do this work today. It is a barrier to the easy access to human studies that is needed for proof-of-concept studies (Phases 1 and 2a). There has been very little trouble in the past 20 years with early INDs filed by responsible individuals, corporations and institutions. The system can now be safety adjusted to recognise this fact, by scaling back the IND requirements for responsible entities, based on what has been learned in the past 40 years. 

The IND filing step, and the oversight of proof-of-concept clinical research, would be safely implemented by cutting back the detail customarily required from pharma sponsors and others (i.e. CROs, Institutions, IRBs and perhaps other entities) that have been formally qualified as responsible in this context. All such sponsors would have been previously screened by the agency, and accepted for the accelerated programme if qualified, based on the applicant s historical record with the agency. 

The general adoption of a first to file system including a grace period for filing patent applications following disclosure by an inventor, with small entity fee reductions would assist smaller companies and may prevent them from losing patent rights to their irmovative products and processes. 

This book was not prepared, approved, or endorsed by any entity associated with the Federal Bureau of Investigation, nor was it prepared, approved, licensed, or endorsed by any entity involved in creating or producing the X-Files TV show. 

The desired result of this screening procedure (which may have to be repeated several times with analogs or congeners of the original molecules) is a lead compound, ie, a leading candidate for a successful new drug. A patent application would be filed for a novel compound (a composition of matter patent) that is efficacious, or for a new and nonobvious therapeutic use (a use patent) for a previously known chemical entity. 

The core of the EntityDictionaryDao is in the retrieve...() methods. Here we assume the entity dictionaries are stored in a relational database. They can also be accessed from other types of data sources, such as web service, XML, and flat files. The point is to transform them into something that can be accessed easily and quickly by CRS. Take a closer look at the retrievePersonnel() method. Like most other retrieve...() methods, retrievePersonnel() returns a Map. What is in the Map depends on what kind of lookups the clients want to use to access the personnel dictionary. In the context of CRS, the personnel data can be accessed by its entirety, the research site where the person is located, person id, person s full name, or person s username. Therefore, the Map that retrievePersonnel() returns has four Collections—an entire personnel list, a site-people map, a person id-person map, a person s full name-person map, and a username-person map. 

Fig. 8. (Opposite page) Example of grid parameter file for use in AutoDock. The file is largely self-explanatory. Reference is made to the grid maps that have been calculated using different molecular entities to probe the interaction with the protein.

As a preliminary matter, the nonprovisional patent application, whether filed in the United States directly or when it enters the U.S. national stage via the PCT, requires that all applicants must be inventors and all of the inventors names and addresses must be provided with the patent application. This is in contrast to many other patent jurisdictions, where the applicant can be a business entity, such as the company an inventor may have assigned his invention to. Additionally, all nonprovisional patent applications require an oath or declaration of inventorship to be included with the patent application or submitted within the prescribed time thereafter. The requirements of the oath or declaration of inventorship are explained in 37 CFR 1.63-1.69. Initial entry of patent applications to the United States from the PCT are governed by the Code as outlined in 35 U.S.C. 371 National stage Commencement. 

---