CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS

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Read the full article: CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS:

""The updated guidance applies to certain biological products licensed under the Public Health Service Act (PHS Act), including in vitro diagnostics licensed under BLAs," though it does not apply to human cells, tissues, and cellular and tissue-based products; specified biotechnology and specified synthetic biological products; and biosimilar biological products subject to licensure under section 351(k) of the PHS Act. "

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FDA Guidance: Regulations Under a Mask? | Bloomberg BNA

Read the full article:  FDA Guidance: Regulations Under a Mask? | Bloomberg BNA:

"The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, undercutting the Administrative Procedure Act and causing excessive burdens on affected industries. The group said the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track of."

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FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

Read the full press release:  Press Announcements > FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections - FDA.gov:

"The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom."

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FDA Finalizes Guidance on Emerging Manufacturing Tech Program | RAPS

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Read the full article: FDA Finalizes Guidance on Emerging Manufacturing Tech Program | RAPS:

"The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing."

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Read the FDA guidance:
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization - FDA (pdf)


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6 Tips To Mix Up Compliance Training - eLearning Industry

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View all of the tips: 6 Tips To Mix Up Compliance Training - eLearning Industry:

"Being creative in how the information is presented and by challenging the staff, the information can have more meaning and, hopefully, stick more in their mind when these topics come up on the job."

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Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World | FDA Voice

Read the full article: Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World | FDA Voice:

"I’m pleased to share an important new advancement to help protect the U.S. and global supply chain for prescription drugs and other medical products. Over the past four years, FDA led a team of international partners to create the Supply Chain Security Toolkit for Medical Products. "

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

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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."

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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."

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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."

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FDA CDER 2017 Guidance Agenda

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

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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."

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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.""

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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)"

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FDA Commissioner Califf Stepping Down on January 20

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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."

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