Generic Drugs

16
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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04
Nov

Question: Which former acting deputy director of OGD just competed in Orange Book Jeopardy at AAMs Virtual GRx-Biosims Conference?

Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]

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21
Sep

FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass.  Released this morning the FDA’s web page (here) asks in its opening line […]

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16
Apr

Day One OGD Generic Drug Forum, Some Statistics

Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program.  There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic […]

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07
Apr
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How Do Bad Facts Become Fake News and Possibly Worse?

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction.  Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S.  While bringing jobs back to the […]

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