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    FDA announces FY 2023-2027 BsUFA science and research priorities

    The US Food and Drug Administration (FDA) on Thursday released a roadmap on its science and research priorities for fiscal years 2023-2027 to spur the development of biosimilars and interchangeable products.   Under the Biosimilar User Fee Amendments (BsuFA) III program, FDA has offered $5 million in funding for several research proposals under the regulatory science pilot program (RELATED: FDA offers funding for biosimilar regulatory science pilot , Regulatory Foc...
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    FDA officials impart lessons learned from quality management maturity pilots

    The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...
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    FDA details approach for finding optimal dosages for new cancer drugs

    The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical development and in it, the agency recommends a new approach in selecting such dosages for modern, targeted oncology drugs.   Historically, dose-finding trials for cytotoxic chemotherapy drugs have been designed to determine the maximum tolerated dose (MTD). The MTD paradigm applies to drugs that have a steep dose-response, have...
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    Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics

    The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...
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    FDA issues draft guidance on dosage and administration labeling

    The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section of prescription drug labeling. Such consistency will ensure that labeling is “pertinent and understandable” to health care practitioners, said the agency.   The draft is a wholesale rewrite of an earlier guidance issued in March 2010, which has now been withdrawn. The new guidance, which is roughly triple the l...
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    Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

    The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...
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    FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices

    The US Food and Drug Administration (FDA) admonished Sun Pharmaceutical Industries in a recent warning letter for a several good manufacturing practice (GMP) violations, including poor aseptic practices, inadequate cleanroom design and environmental monitoring and failure to keep manufacturing equipment clean.   These violations prompted FDA to place the firm on import alert on 7 December.   FDA inspected the firm’s Gujarat India facility from 26 April to 9 May 202...
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    Industry calls for flexibility in FDA’s pediatric measurement guidance

    A pharmaceutical trade group and several drugmakers urged the US Food and Drug Administration (FDA) to take a more flexible approach in its guidance on pediatric measurements in clinical trials and questioned whether 12 months is sufficient to provide meaningful information for growth and development.   These comments were made in response to the agency’s call for feedback on the draft guidance, which outlines ways sponsors can measure pediatric growth consistently in ...
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    FDA finalizes guidance on REMS format and content

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and mitigation strategy (REMS) document for certain high-risk prescription drugs and biologics that pose safety concerns and incorporates “extensive” stakeholder feedback, said the agency.   The draft version of the guidance was first issued for comment in 2017. (RELATED: REMS Format and Content: FDA Offers Draft Guidanc...
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    Starting out as an ad promo reviewer

    This article provides a brief overview of what to expect when starting out as a regulatory advertising and promotion (ad promo) reviewer and includes recommendations for some basic introductory resources.   Keywords – advertising and promotion, regulations, reviewing, starting out   Introduction Regulatory ad promo review is more an art than a science, and learning how to apply the specific laws, regulations, and guidances is an ongoing process. There is a lot...
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    FDA draft guidance on controlled correspondence reflects GDUFA III commitments

    The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency through the controlled correspondence process. The guidance reflects the changes that were part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and expands the topics that are eligible for controlled correspondence as compared to previous iterations of the program.   The GDUFA III comm...
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    FDA guidance proposes devices be deemed adulterated for refusing inspections

    The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.   The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be dee...