Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs - FDA.gov

• Respected FDA GMP online training courses taught by SkillsPlus Intl Inc.

Learn more:  FDA Organization > Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs - FDA.gov:

"Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training

Senate Confirms Scott Gottlieb to Head F.D.A. - The New York Times

Read the full article: Senate Confirms Scott Gottlieb to Head F.D.A. - The New York Times:

"The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Senate Holds Confirmation Hearing on Gottlieb - Policy and Medicine

Learn more about Gottlieb: Senate Holds Confirmation Hearing on Gottlieb - Policy and Medicine:

"The question and answer period of the hearing was extensive, with conversation about many hot topics, including the hiring freeze, opioids, and conflicts of interest."

'via Blog this'


Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA CDER Guidance Agenda

Updated February 7, 2026

The original link broke.

You might also like:

Guidances | Drugs - FDA.gov:

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

---  the original post follows below  ---

View this FDA document:  Guidance Agenda: New & Revised Draft Guidances CDER is planning to publish during calendar year 2017 (pdf)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

U.S. FDA Nominee Moves to Untangle Potential Conflicts of Interest - Food Quality & Safety

Read the full article: U.S. FDA Nominee Moves to Untangle Potential Conflicts of Interest - Food Quality & Safety:

"Gottlieb’s financial ties to the healthcare industry are extensive. If confirmed he has agreed to recuse himself from matters in which he has a financial interest and divest his holdings in about 20 mostly small healthcare companies."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS

Read the full article: FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS:

"FDA spokesperson Lyndsay Meyer confirmed to Focus that the long-planned program alignment for ORA will kick off on 15 May 2017, saying the office "will be moving away from a geographic (regional) management model and align with a commodity-based program structure. All regional food and drug directors (RFDDs), regional directors and regional staff will transition into other positions in ORA.""

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Orange Book Updated - Approved Drug Products with Therapeutic Equivalence Evaluations

Go to the main webpage:  Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book):

"Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

FDA Commissioner Califf Stepping Down on January 20

• FDA CGMP Online Training - trusted GMP online training provided by SkillsPlus International Inc.

Read the full article: FDA Commissioner Califf Stepping Down on January 20:

""His last day will be January 20, 2017, at noon, as per the traditional presidential transition process," FDA spokeswoman Jennifer Rodriguez told Medscape Medical News."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

Two candidates on Trump short list for FDA commissioner - BioCentury.com

Read the full article: Two candidates on Trump short list for FDA commissioner - BioCentury.com:

"President-elect Donald Trump's transition team has two candidates on the short list for FDA commissioner, a source on the team told BioCentury. In addition to Scott Gottlieb, a resident scholar at the American Enterprise Institute who previously has been tipped for the job, the team is considering Jim O'Neill, a managing director at Mithril Capital. That firm was co-founded by Peter Thiel, a Silicon Valley entrepreneur who was an early backer of Trump's presidential campaign. "

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog

• FDA GMP Online Training - recommended CGMP online training courses provided by SkillsPlus International Inc.

Read the full article: Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog:

"Millennials who had observed serious misconduct, more than two-thirds reported it, including such offenses as theft, falsifying expense reports or time sheets, harassment or abuse, and bribery. Millennials, like any other employee, know when something is wrong, illegal, or will harm the company. They simply do not see that social media is “harmful,” any more than older employees viewed gossiping at the bar on Friday night was “harmful.”"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training