New Drugs

12
Feb
financial spreadsheet report

Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

   The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products).  The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]

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02
Jul

How To Address Nitrosamines In The Pharmaceutical World

Contract Pharma published an article back in May discussing the issue of Nitrosamines uninvitedly found in drug products. The article’s author, Aloka Srinivasan, VP of Lachman Consultants, helps us better understand the presence of Nitrosamines and how to address them. Nitrosamines has recently re-surfaced in the pharmaceutical world due to FDA and other international agencies […]

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01
Jul

FDA Issues Two New Labeling Guidances to Aid Sponsors

The FDA announced the availability of two draft labeling guidance documents today.  One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human […]

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26
Jun

The Agency Speaks to Its Effort for Modernizing FDA’s New Drugs Regulatory Program

Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment […]

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14
May

Generics and the News – Bad Start to the Week or Just Business as Usual?

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was […]

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