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    FDA proposes easing blood donor requirements

    The US Food and Drug Administration (FDA) proposed major changes to its blood donation policies that would make it easier for gay and bisexual men to donate blood. The agency said it will use gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted human immunodeficiency viruses (HIV) rather than the time-based deferral system that is currently in place.   Over the past decade, FDA has relaxed donor eligibility requirements that h...
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    Vaccine adcomm recommends harmonizing COVID-19 shots

    A panel of vaccine and infectious disease experts recommends that the US Food and Drug Administration (FDA) harmonize COVID-19 vaccine composition and base future shots on the most prevalent circulating strain or strains of the SARS-CoV-2 virus.   At a 26 January virtual meeting of the FDA Vaccines and Related Biological Products Advisory Committee, FDA officials said that the agency supports the use of the same vaccine strain composition for primary series and boost...
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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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    ICH adopts Q9 guidelines on quality risk management

    The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages.   The ICH Q9(R1) guideline was published on 20 January, and updates the original guideline, which is now 18 years old. It covers the principles of QRM, the general QRM process, risk mana...
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    FDA to stay the course on orphan exclusivity post-Catalyst

    The US Food and Drug Administration (FDA) will continue to apply orphan drug exclusivity according to its regulations, as it did prior to the Catalyst Pharms., Inc. v. Becerra ruling.   The agency’s “longstanding” interpretation of the Orphan Drug Act ’s exclusivity provision was thrown into question following the Catalyst decision in September 2021.   Under the 1983 Orphan Drug Act , drug approved to treat rare diseases can get seven years of market exclusiv...
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    Califf: Current evidence generation system in clinical research needs an overhaul

    Clinical research in the US needs an overhaul to better optimize health outcomes in a way that matches advances in biomedical science, according to a recent perspective authored by US Food and Drug Administration Commissioner Robert M. Califf, published in Clinical Trials journal.   “Biomedical science and technology are undergoing a remarkable period of discovery and development, one driven in large part by the innovations of US scientists and engineers. Unfortunate...
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    FDA finalizes guidance on cannabis clinical research

    The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law.   When Congress passed the Agriculture Improvement Act of 2018 , also known as the 2018 Farm Bill, it defined hemp as including cannabis and derivatives or extracts of cannabis with “a delta-9 tetrahydrocannabinol (THC) conce...
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    Comments: Affordability and education are key issues in naloxone OTC move

    The US Food and Drug Administration’s recent preliminary assessment that some naloxone products are safe and effective for over-the-counter (OTC) use received overwhelming support in public comments, but stakeholders also raised concerns about affordability, end-user education and the need to include products delivered via intramuscular injection. In November 2022, FDA published a preliminary assessment that nasal sprays that deliver up to 4 mg of naloxone, as well as i...
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    FDA final rule reduces radiological devices reporting requirements

    The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will substantially reduce the administrative burdens for itself and the medical device industry.   Following a public consultation, FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedu...
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    FDA issues draft guidance on mpox drug development

    In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule, which enables the agency to approve products without human clinical trials in limited circumstances.   The agency also said that sponsors should talk to regulators early to discuss appropriate clinical trial designs and metrics to prove safety and efficacy. The guidance ...
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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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    Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing

    US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but said it could be improved by incorporating continuous manufacturing principles and clarifying materials testing recommendations.   These comments were made in response to FDA’s release of the Q5A(R2) guideline for public comment in November 2022. The deadline for comments was 13 January....