FDA Roundup: Sept. 9-16, 2025 - Ad/Promo Ramp Up; Cosmetic Adverse Events; New Analgesics Guidance; GCP Final Guidance; and Notable Approvals

FDA has been busy this past week, with some surprises and some hotly-anticipated moves.

1) Advertising and promotion: FDA steps up oversight of prescription‑drug advertising

The Food and Drug Administration announced a crackdown on deceptive prescription‑drug advertising, including warning and cease‑and‑desist letters, and signaled plans to strengthen requirements for full safety disclosures in consumer advertising. See the FDA press announcement.

Consider:

·  Running a red‑team review of all consumer‑facing advertisements for fair balance, avoidance of material omissions, readable risk information, and accurate overall impression in short‑form video.

·  Updating influencer and affiliate agreements to require training, pre‑clearance of content, ongoing monitoring, swift takedown rights, and indemnification for non‑compliant content.

·   Reworking the “adequate provision” approach for social media and connected television to include on‑screen risk cues and compliant landing pages.

·   Centralizing substantiation files for all claims and archive final versions of advertisements and related approvals.

2) Real‑time adverse event dashboard for cosmetic products

The Food and Drug Administration launched a public, real‑time adverse event dashboard for cosmetic products, making it easier to search reports submitted under the Modernization of Cosmetics Regulation Act of 2022. See the FDA press announcement.

Consider:

·    Adding the cosmetic adverse event dashboard to signal‑detection workflows and assigning an owner for weekly review.

·    Updating reporting processes for serious adverse events and ensure product and facility recordkeeping meet the Modernization of Cosmetics Regulation Act of 2022 requirements.

·    Amending vendor and retailer agreements to require timely sharing of adverse event data and cooperation during recalls.

·    Reviewing high‑volume product claims for implied safety or efficacy and align consumer‑facing language with substantiation.

3) Draft guidance on developing non‑opioid analgesics for chronic pain

The Food and Drug Administration issued draft guidance to help sponsors design phase 3 trials of non‑opioid analgesics for chronic pain, with recommendations on trial design, patient selection, rescue‑medication rules, and meaningful outcomes. See the Draft guidance page.

Consider:

·    Comparing pivotal study designs against the draft guidance, including endpoints, duration, rescue‑medication handling, and enrichment strategies.

·    Preparing a focused comment for the public docket; monitoring comments of other key stakeholders

·    Refreshing questions for Investigational New Drug and end‑of‑phase 2 meetings to reflect new expectations.

·    Updating statistical analysis plans and monitoring plans to capture misuse, abuse, and rescue‑medication use.

4) Final ICH E6(R3) Good Clinical Practice guidance

The Food and Drug Administration finalized the ICH E6(R3) Good Clinical Practice guidance, emphasizing quality‑by‑design and proportionate, risk‑based oversight, and enabling modern technology for trial conduct. See the Final guidance page.

Consider:

·   Conducting a privileged gap assessment of standard operating procedures versus the new guidance, focusing on risk‑based quality management, vendor oversight, and digital source data.

·    Amending statements of work with contract research organizations and technology vendors to include deliverables for risk‑based quality management and data‑integrity responsibilities.

·    Revising monitoring plans to use risk‑based and triggered approaches, and retrain investigators and study teams accordingly.

·    Validating remote and electronic source workflows to ensure privacy and data integrity, and prepare for inspections.

5) Approval: Selumetinib for younger pediatric patients with neurofibromatosis type 1

The Food and Drug Administration approved selumetinib (Koselugo) granules and capsules for pediatric patients one year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. See the FDA approval summary.

Consider:

·   Updating labeling libraries, educational materials for health care professionals and patients, and market access dossiers; monitoring payer policy updates for the younger age group.

·    Ensuring promotional review aligns with the revised indication and dosage forms for the expanded pediatric population.

6) Approval: Gemcitabine intravesical system (Inlexzo) for bladder cancer

The Food and Drug Administration approved the gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette‑Guérin–unresponsive, non‑muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The product is co‑packaged with a urinary catheter and stylet for insertion into the bladder. See the FDA approval summary.

Consider:

·       Mapping distribution and practice logistics, including drug‑device handling, unique device identification, and Medical Device Reporting responsibilities.

·       Preparing coding and coverage guidance for urology practices and confirm compliant financial arrangements for office‑based use.

Disclaimer

This post provides general information, does not constitute legal advice, and the applicability depends on particular circumstances. Please reach out to discuss how these developments may apply to you.