Pharmaceutical industry agencies

Regulatory agencies currently set stringent standards on the quantities of nucleic acids allowed in recombinant biological products. In the pharmaceutical industry these requirements necessitate the quantification of trace amounts of nucleic acids in the presence of large quantities of protein and other excipients. Flourescence methods offer advantages for such analyses, but also have limitations. The use of a variety of fluorescent dyes and techniques is described here, and practical examples of such use are presented. 

With all the technology found in the modern hospital today, the lack of coordination between other parts of health care, the pharmaceutical industry, and the agencies is outdated. A network that connects these parts together will improve patient safety, improve care, speed the development of new treatments, and support new medical breakthroughs. 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

To solicit advice from the pharmaceutical industry and government regulatory agencies on candidate articles for harmonization and their relative priorities, and... 

The first attempt at soliciting advice for pharmacopeial priorities was the joint issuance of a letter in May 1990 by the USP in English, by the EP in English and French, and by the JP in Japanese [11]. It went to the regulatory agencies and pharmaceutical industry associations in the cormtries and regions served by each of these pharmacopeias. Reflecting the sentiments of the speakers at the 1989 conferences, the letter was devoted to pharmaceutical excipients and asked only three questions. 

The business model of the innovative pharmaceutical industry is to transform the results of basic medical research into products that provide health benefits to the patient. This model is characterized by a high risk of failure in the development of new products, coupled with the benefit of market exclusivity for a number of years if a product can be successfully developed and is approved by the regulatory agencies. Only very few chemical entities complete the development process from drug discovery to a commercial product. But those products that do reach the marketplace have to yield sufficient financial rewards to assure that the... 

Of partieular interest is the PAT guidance, finalized in September 2004. Unlike the ehemical, petroleum, polymer and food industries, the pharmaceutical industry is under heavy regulatory serutiny. This is not just regulation by the FDA, but regulatory agencies worldwide. The delivery of safe and effeetive drug product to improve the quality of life neeessitates regulation. 

ENVIRONMENTAL PROTECTION AGENCY EFFLUENT LIMITATIONS FOR THE PHARMACEUTICAL INDUSTRY... 

Struzeski, E.J. Waste Treatment and Disposal Methods for the Pharmaceutical Industry. NEIC-Report EPA 330/1-75-001 U.S. Environmental Protection Agency, Office of Enforcement, National Field Investigation Center Denver, CO, 1975. 

It is fair to say that dialogue needs to continue between the Agency and the pharmaceutical industry regarding the terminology that the requirement of ALL contraindications, warnings, precautions and side-effects will mandate and its usefulness in informing patients. The question of roll-up warnings remains a subject for discussion, as does a debate about the difference between adverse events and adverse reactions. 

Other problems facing regulatory agencies and the pharmaceutical industry... 

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