FDA Policy/General
Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS) have introduced the Protecting Patients from Deceptive Drug Ads Act to improve FDA oversights of drug ads by social media influencers and telehealth companies. A statement issued by Durbin says there generally is a gap in FDA oversight when it
Drugs
Partnership for Safe Medicines (PSM) has released a new report that found “suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity injectables (commonly known as weight loss drugs) are flooding into the U.S. from foreign sources despite U.S. laws forbidding them from coming through the border.” Despite
Drugs
Supernus Pharmaceuticals is reporting that a Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale total score to Week 4. “There was no treatment difference
Drugs
FDA has approved an expanded access program authorizing ImmunityBio to provide recombinant BCG to urologists to address the TICE BCG shortage to treat bladder cancer. A company statement says the alternative BCG source was developed by the Serum Institute of India. Recombinant BCG (Bacillus Calmette-Guérin) is described as a
Biologics
In a Hyman, Phelps & McNamara FDA Law Blog post, principal regulatory device and biologics expert Richard Lewis, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The post
FDA Policy/General
Advamed president Scott Whitaker has written HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care. “Device review times were already too long, though they were improving as the result of our latest user-fee agreement,” Whitaker said in a Linkedin post
Drugs
FDA has issued a refusal to file letter for Harmony Biosciences’ Wakix (pitolisant) to treat excessive daytime sleepiness in adults with idiopathic hypersomnia. A company statement says the company plans to continue with a pivotal Phase 3 study based on FDA input. “We believe this study design will effectively demonstrate
Drugs
A bipartisan coalition of 37 state Attorneys General (AGs) is urging FDA to take enforcement actions against online sellers of “harmful counterfeit versions of popular weight-loss and diabetes drugs like Ozempic, Wegovy, Mounjaro, and Zepbound.” In a 2/19 letter to the agency, the AGs warn that counterfeit GLP-
Drugs
The Sedgwick “State of the Nation 2025” report shows that medical device recalls increased 8.6% in 2024, from 975 recalls in 2023 to 1,059 in 2024. The report finds that drug recalls dropped 31%, from 571 in 2023 to 356 in 2024. Device failure was the leading recall
Devices
Becton Dickinson has recalled one lot of ChloraPrep clear 1 mL applicators due to fungal contamination observed under certain environmental conditions allowing Aspergillus penicillioides to grow. Any fungal presence within the device packaging can contaminate the applicator’s surface or gloved hands of a healthcare professional and then consequently the
Drugs
A 3/20-4/3/2024 FDA inspection at the Jagsonpal Pharmaceuticals drug manufacturing facility in Gurugram, Haryana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) and other violations. A 2/5 Warning Letter says specific deviations and violations were: * failure of
Drugs
An 8/12-8/16/2024 FDA inspection at the Tyche Industries drug manufacturing facility in Kakinada, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/6 Warning Letter says specific violations were: * failure to record all quality-related
Devices
Harmed Americans for Reform in Medical Device Safety (HARMS), an organization with no Internet presence and no information available in a Google search, is petitioning FDA to evaluate new studies and publish guidance or public information on robotic mastectomy to treat breast cancer. The petition, which was signed by cardiothoracic
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
Biologics
FDA has approved a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis which commonly cause invasive meningococcal disease (IMD), according to the company. “The vaccine combines the
FDA Policy/General
The Trump Administration fired hundreds of FDA probationary employees over the weekend as part of its efforts to shrink government spending. Media reports indicated that a substantial number of terminations were at CDRH, and it appears that cuts to staff were widespread and affected those conducting drug inspections and working
Drugs
FDA has approved a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. TGCT is a rare, non-malignant tumor that forms within or near joints, according
Drugs
AlgoTx says that based on mixed results from the Phase 2 ACT trial, it sees a path to continue to develop ATX01, its first-in-class therapeutic for chemotherapy-induced peripheral neuropathic pain. A company announcement said the trial “provided encouraging signs of ATX01 efficacy, particularly at the higher concentration
Drugs
FDA has accepted for priority review a Gilead Sciences NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for use in preventing HIV as pre-exposure prophylaxis. The agency has set a review action target date of 6/19. The submission is based on data from the Phase
Biologics
Shortly after Robert F. Kennedy, Jr., was confirmed as HHS secretary, Citizens MAHA (Mobilizing Advocacy to Heal America) filed a petition asking HHS and FDA to “suspend and revoke emergency use authorization and biologics licensure for mRNA Covid-19 vaccines and to conduct a comprehensive safety review due to unprecedented
FDA Policy/General
[Obituary by Jim Dickinson, his friend] Back in the so-called Good Old Days before user fees leveled the playing field, FDA bureaucrats ruled the regulatory roost, secure in their Chevron USA v NRDC power to assert their will until one quiet-spoken lawyer defeated them in a little-noticed
Drugs
ICU Medical is recalling one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag. The company says it has received a customer complaint which states that the 20 mEq bags have incorrect overwrap labels which state 10 mEq. If a healthcare provider mistakenly calculates the