FDA Policy/General
U.S. Sen. Susan Collins (R-ME) used a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing generics and biosimilars to market and promoting her own legislative proposals aimed at reducing prices. During a Senate Health, Education, Labor, and
FDA Policy/General
FDA has classified a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices without recommended updates could lead to serious injury or death. The action affects multiple models in the Philips Respironics Trilogy Evo platform, including Trilogy Evo, Trilogy EV300,
FDA Policy/General
President Donald Trump has nominated Dr. Erica Schwartz, a former deputy surgeon general in the first Trump administration, who spent 24 years in the U.S. Public Health Service Commissioned Corps and also was a Coast Guard rear admiral, to the post of director of the Centers for Disease Control
FDA Policy/General
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, following positive topline results from its Phase 3 ACHIEVE-4 trial. The company said the oral GLP-1 receptor agonist met its primary cardiovascular
FDA Policy/General
FDA was a recurring point of reference during a 4/16 House budget hearing featuring HHS secretary Robert F. Kennedy Jr., as lawmakers pressed the administration on drug regulation, approval timelines, and the broader competitiveness of U.S. biomedical policy. While the hearing was centered on HHS budget priorities and
FDA Policy/General
A senior FDA official is poised to play a key role in a potential leadership overhaul at the Centers for Disease Control and Prevention, as the White House weighs naming president Trump’s former deputy U.S. surgeon general Erica Schwartz as director, according to multiple reports. Sarah Brenner, currently
FDA Policy/General
FDA has issued an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications, reinforcing a risk-based approach to oversight while tightening timelines for communication and follow-up. The program, released 4/14 and set to take effect 5/14, outlines procedures for pre-
FDA Policy/General
CDER has issued two Manuals of Policies and Procedures (MAPP) on postmarketing requirements. MAPP 6010.9 Rev. 1, Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments, applies to the development of all reportable 506B postmarketing commitments (PMCs) for drugs and licensed biological products regulated by CDER, and the communication
FDA Policy/General
A new policy analysis from the Cato Institute is calling on FDA to modernize its regulatory framework for artificial intelligence (AI) in healthcare, arguing that current rules are slowing innovation and discouraging companies from developing high-impact medical tools. In the 4/13 blog post, authors Christopher Gardner and Kevin
FDA Policy/General
Representative Jake Auchincloss (D-MA) is urging FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers. “FDA Commissioner Marty Makary’s incompetence and poor stewardship are undermining the Food and Drug Administration,” Achincloss says in a video posted on X. “Multiple former senior FDA officials have
FDA Policy/General
The homepage of the consumer Web site for BioCorRx Pharmaceuticals’ Lucemyra (lofexidine) tablets for oral use is false and misleading, according to a 3/27 Untitled Letter issued by the CDER Office of Prescription Drug Promotion (OPDP). The letter says the homepage includes a claim that Lucemyra is the only
FDA Policy/General
Attorneys Charles Snow and Dara Levy (Hyman, Phelps & McNamara) say a bipartisan effort led by Sens. Richard Durbin (D-IL) and Roger Marshall (R-KS) to push FDA to take a more positive role in early review of prescription drug direct-to-consumer ads, coupled with heightened FDA enforcement
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. has been told by the White House to tone down and curtail his public commentary on vaccines as part of a deliberate political strategy by the Trump administration, according to a newly revealed internal memo reported by Bloomberg. The memo outlines a “low-risk
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