Wednesday: FDA commissioner | TheHill

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Read the full post:  Wednesday: FDA commissioner | TheHill:

"The Senate will take a final vote Wednesday on President Obama's nominee to lead the Food and Drug Administration.

The vote on Robert Califf's nomination to be the next FDA commissioner comes after senators overwhelmingly agreed to end debate on the nomination Monday in a 80-6 procedural vote. "

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Robert Califf Senate vote could clear path to top FDA job - STAT News

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Read the full article: Robert Califf Senate vote could clear path to top FDA job - STAT News:

"In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him."

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Major shift ahead in how FDA regulates drug quality: PwC

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Updated June 27, 2022

The link to the original source article broke.

---  the original post follows below  ---

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

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Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine

Read the full report: An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine:

"An increasing number of senators are threatening to block Dr. Robert Califf's nomination to be the next Commissioner of the U.S. Food and Drug Administration. The story illustrates an unusual coalition of right and left-leaning members of the Senate, and common refrains about "industry ties" in government and medicine. Ultimately, arcane Senate rules allow the entire process to be stalled by these individual members of the body."

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FDA Orange Book - Newest Annual Edition Has Arrived!

It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs | FDA Voice

Read the full blog post: Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs | FDA Voice:

"To clarify the mission and scope of the ETT, we’ve recently issued a draft guidance titled, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. It provides recommendations to pharmaceutical companies on effective ways to work with the ETT. The document explains the ETT and provides specific recommendations to drug manufacturers for obtaining important early feedback from the FDA regarding their efforts to develop novel manufacturing technologies."

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