2011 Biosimilars Labelling 
FDA Law Blog: Biosimilars
NOVEMBER 14, 2024
More recently, the agency invested significant efforts in modernizing nutrition labeling requirements and implementing a sodium reduction initiative. However, it’s fair to say that FDA’s food program has focused primarily on implementation of the many mandates in the Food Safety Modernization Act of 2011.
FDA Law Blog: Biosimilars
MAY 23, 2023
Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.
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European Pharmaceutical Review
JULY 4, 2024
However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. Herbal medicines placed on the market since April 2011 must have either a traditional herbal registration (THR) or a Marketing Authorisation (MA). 2012/1916).
FDA Law Blog: Biosimilars
FEBRUARY 28, 2024
This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.
FDA Law Blog: Biosimilars
MAY 11, 2023
GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.
pharmaphorum
FEBRUARY 5, 2021
The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. He’s been closely linked to the full time job since Biden was sworn in and formerly worked as principal deputy commissioner of the FDA from 2009 until 2011. Dr Janet Woodcock.
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