Long Post: What’s going on with these so-called Complete Response Letters (CRLs)? There’s long been strong public and investor interest in CRLs, the letters the FDA issues to companies explaining exactly why a drug application (deficiencies in safety, efficacy, manufacturing, ...). FDA launched a major “radical transparency” push in 2025 under then-Commissioner Marty Makary. In July 2025 the agency released more than 200 CRLs, mostly for previously approved applications. In September 2025 it announced real-time or prompt public release of newly issued CRLs (including for pending or withdrawn or unapproved applications) and released another batch of 89. Some real-time style releases followed before the later pause. Industry pushback followed, including a citizen petition filed on April 20, 2026 (by Covington & Burling on behalf of an unnamed pharmaceutical company). The petition raised concerns about process, redactions, and legal authority for disclosing CRLs tied to unapproved applications. FDA reportedly paused new real-time releases around April 2026. An HHS spokesperson later confirmed the temporary pause while the agency evaluates next steps. The agency is now moving to formalize and expand the policy through rulemaking under RIN 0910-AJ16 (“Proactive Disclosure of Complete Response Letters”). On the roughly 9–18 month timeframe: This is a realistic ballpark based on how federal rulemaking usually works. From an NPRM (expected October 2026) you typically get a public comment period (often 30–60 days), agency review of comments, internal clearances (including OIRA review for significant rules), and final publication. Many rules take 6–12+ months from proposal to final rule, and complex or contested ones can stretch longer, sometimes well over a year. That’s standard across agencies and described in guides such as the Federal Register’s overview of the rulemaking process. Key links: Proposed rule (Unified Agenda): reginfo.gov/public/do/eAgend… Citizen petition (April 20, 2026): regulations.gov/document/FDA… openFDA CRL database: open.fda.gov/apis/transparen… This is what I have gathered so far from public sources and reporting. It is not an exhaustive deep dive. Things can move or change once the NPRM is published in October.