23
Jan
Bending, Breaking or Moving On Image

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety […]

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19
Jan
Future Green Road Sign Over Dramatic Clouds and Sky.

Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see […]

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12
Jan
Elderly stylish attractive blond woman coughing or sneezing into her hand as she stands on a rural lane on a misty winter day

No More Pediatric Labeling for Codeine or Hydrocodone Cough Syrups

The FDA announced today that they are revising labeling to remove any indication for codeine or hydrocodone-containing cough cold products for use in patient under the age of 18. The FDA Safety Communication (here) states: “We are taking this action after conducting an extensive review and convening a panel of outside experts.  Both of these […]

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05
Jan

DUE FEBRUARY 14, 2018 – One-Time Report on Marketing Status Required by FDARA- Don’t Forget!

To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book.  The deadline is approaching and FDA even republished its advice to industry (here) again today! Don’t be left without a retort – be sure to submit […]

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