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
Drugs
FDA is convening a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for rare diseases. The workshop is part of a broader agency effort to accelerate rare disease drug development under mandates tied to the FDA User Fee Reauthorization Act of
Drugs
Insmed says it will discontinue development of its drug candidate brensocatib for hidradenitis suppurativa (HS) after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints. HS is a chronic, non-contagious inflammatory skin disease characterized by painful lumps (nodules/boils) that form under the skin,
Drugs
Drug companies that operate in both the U.S. and the European Union (EU) should treat supply chain strategy as a core regulatory function and not an afterthought. That’s the key takeaway from attorney Winston Kirton (Baker Hostetler) in a recent Regulatory Horizons podcast on how regulatory practices in
Drugs
An online Clinical Trial Vanguard post says FDA has not kept pace with the advancing science of oncology-based basket trials migrating into non-oncology drug trials. “FDA’s guidance on master protocols, covering basket, umbrella, and platform trials, was finalized in 2022 and is explicitly anchored to oncology use
Drugs
FDA has lifted a partial clinical hold against MacroGenics’ Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab, allowing the company to resume patient enrollment. The hold had previously paused the addition of new participants, though patients already enrolled were permitted to continue receiving treatment. With the restriction lifted,
Drugs
While individualized and shortage drug compounding are necessary exceptions to FDA standards, mass compounding of commercially available drugs is not. That’s the view of FDA Matters founder Steven Grossman and Nancy Glick, director of food and nutrition policy at the National Consumers League. In an FDA Matters column, the
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
Drugs
FDA has announced a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the safety of drugs and biologics during pregnancy. The 5/7-8 workshop is part of a broader effort to strengthen the generation of high-quality human safety
Biologics
Organogenesis says it has reached a key regulatory milestone for its knee osteoarthritis treatment ReNu, following a Type B meeting with FDA that has cleared the way for a rolling BLA submission later this year. ReNu, a cryopreserved amniotic suspension allograft, is being developed to treat symptomatic knee osteoarthritis, a
Devices
A 12/1-12/12/2025 FDA inspection at the Medline Industries NAMIC Division facility in Glens Falls, NY, found Quality System Regulation violations in the firm’s manufacturing and assembly of numerous medical devices into cardiovascular procedure kits. A 3/25 Warning Letter says the specific violations were: * failure
Devices
FDA has opened the selection phase of its Reducing Readmissions through Device Innovation for the Home (READI-Home) innovation challenge, which is intended to accelerate patient access to medical device technologies aimed at reducing hospital readmissions. An agency post invites innovators to pursue potential participation in the challenge by providing
Drugs
A coalition of 20 healthcare, consumer, and policy organizations is calling on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowering prescription drug costs by curbing patent practices and preserving generic competition. In a 4/6 letter to Jim Jordan (R-OH), chairman of the House
Drugs
FDA has accepted an Outlook Therapeutics formal dispute resolution request (FDRR) regarding the agency’s prior rejection of eye disease therapy ONS-5010/Lytenava (bevacizumab-vikg), setting up a high-stakes meeting later this month. The dispute stems from a December complete response letter (CRL) on the company’s BLA
Drugs
A federal judge 4/7 declined to immediately restrict access to the abortion pill mifepristone, instead pausing a high-profile lawsuit brought by Louisiana and allowing current nationwide access — including distribution by mail — to continue for now. In a ruling that temporarily favors the status quo, U.S. district judge
Drugs
The National Organization for Rare Disorders (NORD) says that as FDA considers what rare disease resources to share and in what format, it should tailor materials towards both developers and patients, so patients can be educated about productive ways to engage in the product development process. The NORD comment came
Biologics
Amgen says it has achieved positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-trbw), potentially paving the way for a more convenient alternative to the currently approved intravenous formulation. The study met its primary endpoint, with patients receiving
Drugs
ImmunityBio says it has responded to FDA’s recent Warning Letter on the company’s alleged misleading promotional claims about its cancer therapy Anktiva (nogapendekin alfa inbakicept-pmln) in both a television advertisement and a podcast appearance by company leadership (see earlier story). The company says it is taking steps
Devices
FDA has cleared an Anumana 510(k) for an artificial intelligence–based tool designed to detect early signs of pulmonary hypertension, a serious and often underdiagnosed cardiovascular condition. The company’s software-as-a-medical-device algorithm is intended to analyze standard 12-lead electrocardiograms (ECGs) to identify subtle indicators
Biologics
FDA has identified deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Germany, following an inspection conducted in April 2024. According to a just-posted FDA Form 483 issued at the close of the inspection, investigators cited the company for failing to adequately
Drugs
FDA’s new draft guidance outlining, for the first time, formal expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current GMP compliance appears to be raising the compliance bar. According to a Cooley legal alert, some aspects of the guidance seem to go