The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature.

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Alta Sciences

SEPTEMBER 20, 2023

Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms.

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Virus Clinical Pharmacology Drugs FDA Approval 40

Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. Data on these novel approvals is published throughout the year by both CDER and CBER. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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FDA Biosimilars Science Production 52

Agency IQ

JUNE 16, 2023

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. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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FDA Science Regulations Production 40