• 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. ...
  • Regulatory NewsRegulatory News

    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...
  • This Week at FDAThis Week at FDA

    This Week at FDA: PDUFA and BsUFA hires, cannabis guidance, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA gave its first quarterly update on its hiring goals under its prescription drug and biosimilar user fee programs. The agency also finalized guidance on quality considerations for cannabis and cannabis-derived drugs and said that a new regulatory pathway is needed for canna...
  • Feature ArticlesFeature Articles

    Regulatory ad promo in a co-promotion setting

    Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: US FDA joins global regulators investigating contaminated cough syrup; AstraZeneca’s Evusheld no longer authorized in the US

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA joins global regulators probing tainted overseas cough syrup ( Reuters ) ( CBS News ) AstraZeneca’s Covid Drug No Longer Authorized for Use in the US ( Bloomberg ) ( STAT ) Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines ( STAT ) Inhibikase, FDA find common ground to lift hold on Parkinson’s drug ( Fierce ) Updated COVID v...
  • RoundupsRoundups

    Euro Roundup: EMA keeps deadline for CTIS switch, says it can fix ‘blocking bugs’ in time

    Use of the Clinical Trials Information System (CTIS) will become mandatory for new applications at the end of the month. EMA retained the deadline after determining that it can resolve the final “blocking bugs” by the go-live date.   When EMA’s management board met last month, the agency outlined a plan to ensure that it fixed all technical issues affecting core CTIS processes in time for mandatory use of the system. The agency  has resolved “more than 80% of the block...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: WHO investigating cough syrup deaths; EU patient groups push for greater measures to address antibiotic shortages

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Many pediatric drug study results were never posted to a U.S. government database ( STAT ) COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel ( Pink Sheet ) US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible ( Pink Sheet ) Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rar...
  • Regulatory NewsRegulatory News

    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...