• Regulatory NewsRegulatory News

    Device experts discuss strategies for breakthrough, STeP submissions at Convergence

    PHOENIX, AZ – Device manufacturers planning to submit applications through the US Food and Drug Administration (FDA)’s two novel device programs, the breakthrough devices program and Safety Technologies Programs (SteP) for Medical Devices, should consider submitting clinical data with their applications and executive summaries of how their devices work, according to experts who spoke on a panel at RAPS 2022 Convergence on 13 September.   They also offered advice on the...
  • Regulatory NewsRegulatory News

    New FDA guidance offers ethical roadmap for including children in clinical trials

    The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.   The guidance , published on 26 September 2022, is aimed at assisting industry, sponsors and institutional review boards (IRBs) when conducting or reviewing clinical investigations of drugs, biological products, and medical devices that involve children. It was developed by FDA’s Office of Pediatric The...
  • Regulatory NewsRegulatory News

    Top OGD official to depart from FDA ahead of GDUFA III

    Sally Choe, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), is leaving the agency after a three-and-a-half-year stint in the role.   Her departure comes just before the agency is expected to begin implementing the third iteration of its Generic Drug User Fee Amendments (GDUFA III) program. While Congress has not formally reauthorized the user fee programs, it is widely expected to include the user fee package as part of a stop gap...
  • ReconRecon

    Recon: Pfizer, Moderna seek EUA for bivalent boosters for kids; Daiichi Sankyo wins Japanese approval for blood cancer drug Ezharmia

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Moderna asks FDA to authorize omicron Covid boosters for children as young as 6 years old ( CNBC ) ( Reuters ) Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11 ( CNBC ) ( Reuters ) Biden to announce $1.5 billion to fight U.S. opioid crisis ( Reuters ) Monkeypox Appears to Recede, but Risks and Uncertainties Linger ( NYTimes ) Seagen, a...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Hope for user fee reauthorization, EMA says COVID-19 pandemic not over yet

    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. The biggest development of the week is news that Congress actually may pass a user fee reauthorization bill. Regulators also have published several major guidances this week including one on electronic submission of 510(k) applications.   While the US Food and Drug Administration has...
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    FDA exempts naloxone distribution from DSCSA tracking requirements

    The US Food and Drug Administration (FDA) announced on Thursday that it will not take enforcement action against distributors of approved naloxone products for treating opioid overdoes under the prescription drug tracking requirements under the Drug Supply Chain Security Act (DSCSA).   The exemption would “help facilitate and expedite the distribution of naloxone to harm reduction programs on the front lines of the opioid overdose crisis, and thus directly aid in add...
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    Convergence: RWE regulatory successes offer lessons for US applications

    PHOENIX, AZ – The use of real-world evidence (RWE) to support US regulatory submissions often suffers from a lack of data reliability or clinical relevance, but there have been some success stories where RWE was considered fit for use.   During a session at RAPS Convergence 2022, speakers shared cases where RWE supported regulatory decision making for marketing applications for a new indication or to answer post-marketing safety questions. These examples are not easily...
  • Regulatory NewsRegulatory News

    FDA plans to study medication adherence claims, endorser effect in DTC advertising

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) said it plans to conduct two studies looking into patient and physician perceptions of medication adherence claims in online ads and how endorser status and actual-use disclosures impact viewers’ perception of drugs in television ads.   On 22 September, OPDP announced its plans to study how online advertisements for drugs that include claims of improved medication adherence are p...
  • RoundupsRoundups

    Euro Roundup: EMA confirms biosimilars are interchangeable in bid to harmonize European approach

    The European Medicines Agency (EMA) has confirmed that biosimilars approved in the European Union are interchangeable with their reference medicines. EMA made the clarification in a joint statement with the Heads of Medicines Agencies (HMA) to harmonize a practice that is adopted in many EU countries.   Prior to the statement, many EU member states had independently decided to allow biosimilars to be used interchangeably with their reference products, thereby supportin...
  • Regulatory NewsRegulatory News

    FDA officials urge ‘comprehensive’ approach to accelerated approval reforms

    Critics of the US Food and Drug Administration’s (FDA) accelerated approval pathway have focused on the need to generate confirmatory evidence faster and to withdraw products that fail to show benefit. But officials in FDA’s Oncology Center of Excellence (OCE) suggest that focus is also needed on different trial designs and end points that could help build quality and efficiency into the front end of the process.   In a perspective in the New England Journal of Medic...
  • ReconRecon

    Recon: HHS OIG criticizes FDA’s EUA policies for COVID tests; ODAC votes against Spectrum’s lung cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA panel votes against Spectrum's lung cancer drug ( Reuters ) FDA Approves Drug for Cisplatin Ototoxicity in Kids With Cancer ( MedPage Today ) ( Reuters ) Lilly’s Retevmo Gets FDA OK for RET Fusion-Positive Solid Tumors ( Bloomberg ) ( Endpoints ) Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules ( MedTech Dive ) ( Reu...
  • Regulatory NewsRegulatory News

    Generic industry urges FDA to eliminate citizen petitions for TE ratings for 505(b)(2) products

    Generic drug industry stakeholders told the US Food and Drug Administration (FDA) to eliminate its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence (TE) evaluations for 505(b)(2) applications, saying this process will not work and will hurt the makers of complex generics. They also requested that FDA not remove from the Orange Book drugs that have been discontinued.   These comments were in response to FDA’s draft guidanc...