About 290 search results for "guidelines for drug tests to be waived"

Notice and Comment – Draft Revised Excessive Price Guidelines (August 2008)


Sep 16, 2014 ... with the four levels of improvement; 3. Alternate processes for bioequivalent and licensed patented generic drug products regarding the selection of comparable drugs and the conduct of the TCC Test and the IPC Test. 4. Guidelines on the conduct of selected any market price reviews at introduction and, thereafter, on a case-by-case basis, as appropriate. 5. Guidance

Overview - Import and Interprovincial Requirements for Fresh Fruit and Vegetables - Canadian Food Inspection Agency


Aug 29, 2016 ... Fruit and Vegetable Regulations and the Food And Drug Regulations. Exemptions to Regulatory Requirements Container, labelling and grade requirements may be waived through the issuance of a Ministerial Exemption (prior to shipment) when there is a shortage of domestic supplies in the receiving province. A ministerial exemption is approved for movement of bulk

Guidelines for Requesting and Administering Ministerial Exemptions for Fresh Fruit and Vegetables - Canadian Food Inspection Agency


Nov 24, 2016 ..., peaches and pears (200 kg in accordance with Test Markets). As such, produce moving in bulk containers (bins, sacks, etc.) in excess of the prescribed weight or without proper markings, whether graded to meet the minimum quality standards or not, do not comply with the regulatory requirements set out in the Regulations for packaging and/or labelling. Under certain

Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs


Feb 8, 2010 ..., and provide supporting data. Supporting data could be based upon concepts of qualification outlined in the VICH and ICH impurity guidelines. 5.3.5 Control of the Drug Substance Specification The submission should contain a copy of the drug substance specification from the company responsible for release testing. The person in charge of quality control

Revised Fee Proposal for Drugs and Medical Devices


Jul 16, 2018 ... products under the Self-Care Framework than the proposed model for drugs and medical devices. Further explanation is required with respect to fees for fabrication, packaging, labelling, testing and importing Active Pharmaceutical Ingredients. More accurate post-market maintenance costs are needed to align Pre-market review costs with Right-to-Sell costs

Guidelines for Preparation of New Drug Submissions for Products Used for Estrogen-Progestin Replacement Therapy in Menopause (HRT)


Mar 19, 2000 ... substantial information already exists on the drug substance(s)), abridged toxicology may be considered or toxicology testing may be waived. A request for waiver or variance should be supported by a strong rationale and discussed with Therapeutic Products Programme staff prior to filing the submission. The following is an example of such a situation: If both estrogen

3.7 Resolution Discussions - PPSC


May 25, 2018 ... or is aware of the right to full disclosure and has clearly waived it.Footnote 25 Any such waivers should be indicated on the court record at the time of entering the plea. Crown counsel may not proceed with a resolution agreement where the charge approval standard set out in the PPSC Deskbook guideline “2.3 Decision to Prosecute” cannot be met.Footnote 26 If the case

3. Findings - The Federal Victim Surcharge in Saskatchewan


May 27, 2014 ... at large (92%) and breaking and entering (91%). The lowest waiver rates were seen in drug possession (59%) and impaired driving cases (43%). Table 4: Federal Victim Surcharge waiver rates by specific offence, 2002/03-2006/07 Offence Total # Sentenced % of Total Total FVS Waived FVS Waiver Rate Homicide 25 .03% 25 100% Attempted Murder 6 .01% 6 100% Robbery 575 .8

Questions and Answers - Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice


Apr 30, 2010 ... that safety and efficacy data from non-clinical studies adhere to GLP? A: The Guidance Document on Good Laboratory Practices applies to non-clinical safety data. Our definition of non-clinical data is consistent with OECD GLP Principles as it applies to all in vitro and in vivo testing, not involving human subjects, performed to determine the safety of human drugs

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