Trump, at Biopharma Meeting, Pledges to 'Streamline' FDA, Cut Regulations but Wants Lower Prices - TheStreet

Read more: Trump, at Biopharma Meeting, Pledges to 'Streamline' FDA, Cut Regulations but Wants Lower Prices - TheStreet:

"Biotech and drugs stocks are soaring Tuesday after President Donald Trump, meeting with CEOs of the biotech and pharma industries, promised to "streamline the FDA" and cut regulations so that new products can be brought to the market faster and cheaper."

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Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut - FDA Law Blog

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Read the full article: FDA Law Blog: Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut:

"On January 25, 2017, The Orange Book data will be updated to reflect the recent publication of the draft guidance for industry ‘Referencing Approved Drug Products in ANDA Submissions."

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Go to the FDA webpage:
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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Rumor mill adds Joseph Gulfo to Trump's shortlist for FDA commissioner | FierceBiotech

Read the full article: Rumor mill adds Joseph Gulfo to Trump's shortlist for FDA commissioner | FierceBiotech:

"If reports are to be believed, the latest addition to Trump's list of possible FDA commissioners is Dr. Joseph Gulfo, an outspoken critic of the agency who has penned a manifesto for its reform.

 Gulfo joins a lengthening list of possible candidates that also includes Scott Gottlieb, a former FDA staffer and partner at venture capital fund New Enterprise Associates, as well as two Silicon Valley figures: tech capitalist Jim O'Neill and Balaji Srinivasan, a specialist in computational biology and tech investor."

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An Alternative to GMP Quality System Auditing in the Pharma Industry | FDAZILLA BLOG

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"Over the past four FDA fiscal years, the percent of warning letters that cite data integrity deficiencies has continued to increase"

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Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA – Respectful Insolence

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Read the full article: Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA – Respectful Insolence:

"a third person under consideration for the position of FDA Commissioner: Balaji Srinivasan. I had never heard of him before, but I quickly learned that Srinivasan is also a Silicon Valley entrepreneur. Like O’Neill, he is not a scientist, but rather CEO of bitcoin start-up 21.com. He is also a partner at venture firm Andreessen Horowitz and teaches at Stanford University. His primary expertise is in the area of digital payments and computational biology, and his expertise in health regulation stems from a start-up company he co-founded, Counsyl Inc., which offers DNA screening, especially for people considering having children."

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