FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a patient brochure for Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly), a biosimilar of Genentech’s Avastin, is false or misleading for multiple reasons. A 3/31 Untitled Letter cites concerns that the brochure: * fails to provide material information about the full FDA-
FDA Policy/General
FDA has cited significant manufacturing and quality control deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy, following a 2/2025 inspection. The inspection identified lapses in quality unit oversight, including failures to properly document and investigate deviations, inadequate control over testing and inspection
FDA Policy/General
Pharmaceutical direct-to-consumer advertisers should treat a legislative proposal in FDA’s recent budget documents (see earlier story) to curb misleading ads as confirmation that enforcement will intensify under this administration. Under the proposal, FDA seeks authority to deem a drug to be misbranded if a DTC drug advertisement
FDA Policy/General
An FDA 3/27-4/16/2025 Bioresearch Monitoring Program inspection of two ophthalmological clinical trials conducted by Dr. Ehsan Sadri in Newport Beach, CA, found that Sadri failed to ensure that the investigations were conducted according to the investigational plan. A 3/27 Warning Letter says his written response
FDA Policy/General
While many government agencies will have to deal with significant budget cuts next year, FDA’s just-released proposed fiscal year 2027 budget seeks a 3.3% increase or about $200 million to fund the agency’s operations. As proposed, the budget would total $7.2 billion, which includes $3.
FDA Policy/General
FDA commissioner Marty Makary this week shared an expansive vision for future medical breakthroughs, telling agency staff (audio link – begins at 47:28 mark) he hopes to see transformative treatments — and potentially cures — across a range of serious diseases in the coming years Speaking about long-term priorities, Makary pointed
FDA Policy/General
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has sparked concern among former agency officials and public health experts. HHS secretary Robert F. Kennedy Jr. has criticized FDA’s earlier action as “illegal,
FDA Policy/General
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlined an expansive agenda to accelerate drug approvals, lower costs, and modernize the agency — while maintaining its core commitment to safety. Makary’s address (available recording), which coincided with his one-year anniversary at FDA, emphasized
FDA Policy/General
Congress could bring direct-to-consumer drug ads into modern times by requiring them to show a QR code for a few seconds on the TV screen so consumers could use a smartphone to access a large-font brief summary or major statement. That’s the recommendation in a Washington
FDA Policy/General
Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission meeting with FDA. At the meeting, FDA advised the company to include a confirmatory clinical trial as part of an accelerated approval pathway submission. Agios says it has already submitted a
FDA Policy/General
FDA is seeking industry and public input on how to expand the use of digital health technologies (DHT) in clinical trials, as part of a broader push to modernize drug and biologic development and regulatory decision-making. DHTs — ranging from wearable sensors and smartphone apps to implantable or ingestible devices
FDA Policy/General
Scholar Rock has resubmitted its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy (SMA), following alignment with FDA on manufacturing and supply issues that previously delayed approval. The resubmission follows a 9/2025 complete response letter that cited inspection findings at a contract manufacturing
FDA Policy/General
An opinion piece published by The Washington Times’ editorial board is drawing attention to growing criticism of FDA commissioner Marty Makary, arguing that his agency leadership reflects ideology overtaking scientific judgment. The editorial takes aim at recent remarks by Makary and personnel decisions within the agency, raising concerns about their
FDA Policy/General
University of Southern California Price School of Public Policy associate professor Genevieve Kanter says policymakers should consider conflict of interest policies to be part of a broader strategy of building public trust by being more trustworthy as an agency. “This includes providing comprehensive scientific justification for decisions, being transparent about
FDA Policy/General
The Government Accountability Office (GAO) says FDA should publicly share information on how it determines whether advisory committee members have conflicts of interest. A GAO report says the agency does not make this information available currently because it has not finalized a required guidance on the matter more than 13
Biologics
A Heartland Institute online newsletter quotes several experts with differing opinions on why CBER director Vinay Prasad is leaving FDA for a second time. The post says that during his tenure, Prasad, in his dual role as CBER director and agency chief medical and scientific officer, “raised concerns about drugs
FDA Policy/General
A new study published in JAMA Network Open highlights growing public health concerns over prescription drug promotion by social media influencers. The systematic review found that influencer-driven marketing frequently spreads misinformation, benefits from weak regulatory oversight, and leverages personal storytelling to increase persuasiveness, often making it difficult for audiences
FDA Policy/General
A pair of public health experts is calling for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent progress. In a Viewpoint published 3/18 in the Journal of the American Medical Association, Irene Ulrich of the Center for Science in the Public
FDA Policy/General
FDA has released an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater clarity on regulatory expectations while reinforcing flexibility in testing approaches. The document, “Pyrogen and Endotoxins Testing—Questions and Answers (Edition 2),” aims to address areas of persistent
FDA Policy/General
Attorneys Nathan Brown and Maddy Bolger (Akin) say regulated industries should assess and incorporate the FDA suggestions in a 3/9 draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, into their form FDA-483 response practices and, in particular, their corrective and
FDA Policy/General
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccines and autism could endanger public health as measles cases climb nationwide. In a letter to HHS secretary Robert F. Kennedy Jr., senators including
FDA Policy/General
FDA has updated an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications, detailing administrative steps used during regulatory review. The document — Standard Operating Policy and Procedure (SOPP) 8401.2 Administrative Processing of BLA and NDA Supplements — provides guidance for staff on the administrative