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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. to include devices.

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