• Regulatory NewsRegulatory News

    FDA proposes streamlining inspections office along with new human foods center

    The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies for ORA, but the reforms will not be as fast as they want due to resource constraints.   In the wake of the infant formula scandal and shortage over the past year, several top lawmakers have called on the FDA to reform its food regulat...
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    FDA releases FY 2022 generic drug research summary

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments (GDUFA III).   The research generated from the program enabled FDA to issue 177 new and revised product-specific guidances (PSGs), 59 of which were for complex products, according to the summary.   “The recommendations in many of th...
  • Feature ArticlesFeature Articles

    Subpart H and the implications for ad promo

    Advertising and promotion (ad promo) of prescription drugs is regulated by the US Food and Drug Administration (FDA). In 1992, the agency implemented Subpart H of Title 21 of the Code of Federal Regulations (CFR) to allow for the accelerated approval of new drugs for serious or life-threatening illnesses. Approval of a drug through the Subpart H pathway introduced a range of regulatory requirements, some of which had specific implications for the ad promo of Subpart H drug...
  • ReconRecon

    Recon: US to end COVID emergencies on 11 May; Amgen launches first Humira biosimilar in US

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. to end COVID-19 emergency declarations on May 11 ( Reuters ) ( Bloomberg ) ( STAT ) As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions ( Pink Sheet ) FDA Launches Plans for Food Program Revamp After Watchdog Review ( Bloomberg ) End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timefr...
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    FDA issues draft guidance on developing drugs for acromegaly

    The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not responded to surgery or are in poor health.   Acromegaly is a chronic, rare disease in adults caused by excess growth hormone that can cause enlarged hands and feet, among other symptoms. The most common cause stems from a growth hormone that stimulates hepatic overproduction of insulin-like growth factor-1 (IGF-1).  ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Medsafe updates overview of new and changed medicine regulation

    The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released a new version of its overview of medicine regulation in the country. Medsafe published the document after carrying out a major review and restructuring of its advice on the approval of new and changed medicines.   While large sections of the guideline remain unchanged, Medsafe has added a new, short section on how to submit an application or notification, explaining that applications ...
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    Experts offer CTIS advice on eve of transition for new applications

    Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS) portal. Companies are either waiting for their colleagues to submit first or are waiting for last-minute technical glitches to be ironed out first, said an expert who recently spoke to Regulatory Focus on CTIS implementation.   Other experts told Focus that while the requirement to submit all new trials to CT...
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    Lasers: FDA publishes guidance on surveying, leveling and alignment products

    The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser product used for surveying, leveling and alignment. While certain products such as laser pointers may harm people if misused, regulators say they will refrain from regulating low-risk products such as lasers used by observatories to make atmospheric measurements.   On 30 January, the FDA finalized its Q&A guidance that answers questio...
  • Regulatory NewsRegulatory News

    FDA to resume in-person formal meetings in February

    After nearly three years of virtual meetings, the US Food and Drug Administration (FDA) on Monday announced it will resume scheduling in-person, face-to-face (FTF) formal meetings with drug and biologics sponsors beginning 13 February 2023.   The shift to virtual meetings took place in the early months of the COVID-19 pandemic, with FDA announcing via guidance that it would hold all CDER and CBER meetings with industry virtually for the duration of the public health em...
  • RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest

    RAPS releases framework addendum and assessment tool for regulatory professionals

    Today, the Regulatory Affairs Professionals Society (RAPS) released its Regulatory Competency Framework Addendum: Performance Criteria , which is an extension of the 2021 Regulatory Competency Framework report . A new performance assessment tool accompanies the framework. “Specifically, the addendum provides performance criteria as outlined in the most recent report,” explained Lindsey Summers, MBA, who served as vice chair of the addendum committee. “Regulatory aff...
  • ReconRecon

    Recon: FDA approves Keytruda as adjuvant for NSCLC; Philips to cut 6,000 more jobs after Q4 losses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting ( Endpoints ) ( FDA ) ( MedPage Today ) Lilly Gets U.S. FDA Approval of Jaypirca to Treat MCL ( Bloomberg ) ( BioSpace ) ( Endpoints ) FDA approves Italy-based pharma's oral SERD for some breast cancer patients ( Endpoints ) ( Fierce ) Drugmakers prevail in dispute over U.S. ...
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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...