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However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
In those early years before the rise of the World Wide Web and HTML documents, PDF was popular mainly in desktop publishing workflows. PDF's adoption in the early days of the format's history was slow. [4] Indeed, the Adobe Board of Directors attempted to cancel the development of the format, as they could see little demand for it. [5]
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
A PDF file is organized using ASCII characters, except for certain elements that may have binary content. The file starts with a header containing a magic number (as a readable string) and the version of the format, for example %PDF-1.7. The format is a subset of a COS ("Carousel" Object Structure) format. [24]
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Inverse benefit law – Drug benefit-harm ratio falls with marketing; List of abbreviations used in medical prescriptions; Medicines reconciliation; Medical device (such as hearing aids, for example) may be specified by a type of prescription; Off-label use – Use of pharmaceuticals for conditions different from that for which they were approved
The Drug Industry Documents Archive (DIDA) is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management. DIDA is a part of the larger UCSF Industry Documents Library which includes the Truth Tobacco Industry Documents.
2009: Gil Kerlikowske, the current Director of the Office of National Drug Control Policy, signaled that the Obama administration would not use the term "War on Drugs," as he claims it is counter-productive and is contrary to the policy favoring treatment over incarceration in trying to reduce drug use. "Being smart about drugs means working to ...