Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Manufacturing Change Supplements

Chemistry, Manufacturing, and Controls Supplement = manufacturing change supplement submissions as provided in 21 CFR314.70,21 CFR314.71,21 CFR314.72 and21 CFR 601.12 ... [Pg.117]

Chemistry, Manufacturing and Controls Supplement = all manufacturing change supplements as required by 21 CFR 314.70,314.71,314.72 and 601.12 except SUPAC supplements ... [Pg.165]

Since the implementation of the PDUFA, the review times for NDAs for new molecular entities have dropped dramatically. In 1993, the median total approval time was 23 months, of which 21 months were used by the FDA, and 25 new molecular entities were approved. By 1996, the median time had dropped to 14.3 months for total time, with a median of 12 months for FDA review, and 53 new entities were approved. Similar reductions in review time and increases in numbers of NDAs reviewed have also occurred for supplements for manufacturing changes and for new clinical indications (16). [Pg.101]

To counter the elevated emissions associated with enrichment, the EPA has adopted supplemental federal test procedures. The new laboratory test procedures contain higher speeds, higher acceleration and deceleration rates, rapid speed changes, and a test that requires the air conditioning to be in operation. These tests increase the probability that vehicles will go into enrichment under laboratory test conditions. Hence, manufacturers have an incentive to reduce the frequency of enrichment occurrence in the real world. Future catalytic converters and emissions control systems will be resistant to the high-temperature conditions associated with engine load, and will be less likely to require enrichment for protection. Thus, enrichment contributions to emissions will continue to decline. [Pg.455]


See other pages where Manufacturing Change Supplements is mentioned: [Pg.156]    [Pg.156]    [Pg.715]    [Pg.156]    [Pg.156]    [Pg.715]    [Pg.418]    [Pg.329]    [Pg.501]    [Pg.519]    [Pg.523]    [Pg.17]    [Pg.30]    [Pg.307]    [Pg.165]    [Pg.174]    [Pg.175]    [Pg.458]    [Pg.1780]    [Pg.1783]    [Pg.3]    [Pg.4]    [Pg.5]    [Pg.110]    [Pg.206]    [Pg.27]    [Pg.415]    [Pg.54]    [Pg.410]    [Pg.311]    [Pg.110]    [Pg.244]    [Pg.587]    [Pg.591]    [Pg.594]    [Pg.612]    [Pg.540]    [Pg.421]    [Pg.2]    [Pg.69]    [Pg.73]    [Pg.325]    [Pg.331]    [Pg.41]    [Pg.46]    [Pg.3]    [Pg.10]    [Pg.292]   
See also in sourсe #XX -- [ Pg.156 ]




SEARCH



© 2024 chempedia.info