Regulatory authority, approvals

Test Sensitivity Detection range Speed Cost/test, excluding staff time Regulatory authority approval Special equipment requirements... 

Progress in the development of nano-sized hybrid therapeutics and nano-sized dmg delivery systems over the last decade has been remarkable. A growing number of products have already secured regulatory authority approval and, in turn, are supported by a healthy clinical development pipeline. They include products used to treat cancer, hepatitis, muscular sclerosis, and growth hormone deficiency. (See Therapeutics Packaging and Nanomedicines in Chapter 7.)... 

The Chemical Abstracts Services Registry Number and lUPAC nomenclature for PVP are [9003-39-8] and l-ethenyl-2-pyrrohdinone homopolymer, respectively however, it is known by a variety of approved names by foreign and domestic regulatory authorities. For example ... 

Regulatory authority authorisation / approval / notification of protocol... 

Regulatory Authority authorisations /approvals / notifications where required... 

It should be noted that all technical data submitted in support of marketing authorisations remain confidential between the applicant and the regulatory authorities. In situations where the manufacturer of a drug substance is a different commercial entity to the applicant seeking approval of a drug product incorporating... 

Surveillance requests are usually targeted at particular concerns, vhich the FDA vill specify as part of the scope of the surveillance order. The manufacturer must submit a plan to the FDA outlining ho v the surveillance vill be conducted. Once approved, the surveillance plan must be put into effect, usually for not more than 3 years, and any reports agreed as part of the plan must be submitted to the FDA. Surveillance plans are quite similar in concept to the safety studies that may be agreed vith regulatory authorities for drugs. 

In Australia, approval of clinical trials involves both the regulatory authority and an ethics committee. Under the Clinical Trial Exemption (CTX) scheme, a clinical trial proposal must first be evaluated by the TGA, and then approved by an ethics committee on-site. Under the Clinical Trial Notification (CTN) scheme, a trial is evaluated and approved by the local ethics committee, and then notified to the TGA. 

Notification or approval by the drug regulatory authority not required. 

Extensive assessments must be completed prior to receiving approval from regulatory authority. 

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