FDA Policy/General
Johnson & Johnson reports that data from Cohort 2 of the Phase 2b SunRISe-1 study evaluating investigational TAR-200 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk, non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ showed a high complete response rate and durability
Drugs
GlycoMimetics says its Phase 3 study of uproleselan combined with chemotherapy in relapsed/refractory acute myeloid leukemia (AML) patients “did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.” The company says it is analyzing the data in collaboration with medical,
Drugs
FDA has released a draft guidance entitled “REMS Logic Model: A Framework to Link Program Design With Assessment. The document describes FDA’s risk evaluation and mitigation strategy (REMS) logic model, which it describes as a recommended framework to provide applicants with a systematic, structured approach to the design, implementation,
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency that they were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” The document describes the factors FDA intends to assess when deciding to issue an enforcement policy on test manufacturers’ unapproved tests and unapproved uses of approved tests
Devices
FDA has cleared a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System. ZygoFix’s device “harnesses the spine’s innate bone structure to securely lock its connecting joints,” the company says. “Unlike traditional methods, the company's innovative implant adapts to the joint's anatomy during
Devices
FDA has cleared a Phonak 510(k) for a self-replacement option for its Phonak Lyric hearing aid. The self-replacement is a hearing professional-guided option for patients who choose to replace their Lyric hearing aids every other time on their own. The company says the self-replacement option
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Adam Paul Runsdorf from providing services in any capacity to a person that has an approved or pending drug product application. The agency order is based on Runsdorf’s felony conviction for conspiring to distribute counterfeit cough syrup under pharmaceutical
Drugs
CDER is announcing a new Quantitative Medicine (QM) Center of Excellence (CoE). “QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care,” an agency notice says.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “#290 (VICH GL61) Pharmaceutical Development,” which was developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. The document describes the suggested contents for the Pharmaceutical Development section, which presents
FDA Policy/General
[Commentary by Jim Dickinson] In an unusually strident critique of FDA’s 4/29 final rule to regulate laboratory developed tests (LDTs) as medical devices, the Wall Street Journal’s editorial board 5/3 accused the agency of “usurping and end-running Congress. We supported Dr. Califf’s nomination [for
Biologics
Regeneron may be facing an approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The company said in a 5/2 earnings call that FDA recently requested sub-population breakdowns from the Phase
FDA Policy/General
Senator J.D. Vance (R-OH) and House Representative Debbie Lesko (R-AZ) have introduced the Fixing Administrations Unethical Corrupt Influence Act (FAUCI Act) to prevent top federal health officials at FDA, CDC and NIH from cashing in on the industries they regulate after leaving their respective agencies. “This legislation
FDA Policy/General
FDA has stepped up its surveillance of promotional materials during inspections, according to a client bulletin by Arnall Golden Gregory. The law firm says several recent Warning Letters to medical device companies have cited unlawful promotions, including the most recently released letter to Spectrum Medical in Gloucestershire, UK. The inspection
Drugs
FDA has announced an 8/16 public meeting on “Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials” to discuss approaches to developing drugs to treat the negative symptoms of schizophrenia and disseminate important regulatory considerations for programs designed to evaluate such drugs. The hybrid meeting requires registration for attending
Drugs
A Eugia Pharma Specialities (an Aurobindo subsidiary) formulation manufacturing facility in Rajasthan, India has been issued a seven-observation FDA Form-483 after being inspected by the agency from 4/25 to 5/3. “The observations are procedural in nature and will be responded to within the stipulated time,” the
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Angela Maria Giron from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases the debarment on a finding that Giron was convicted of a felony for conduct relating to the
Devices
Senior medical device regulation expert Lisa Baumhardt (Hyman, Phelps & McNamara) says aspects of a recent FDA draft guidance on Requests for Feedback and Meetings for Medical Device Submission: The Q-Submission Program “could have a negative impact on future pre-submissions.” Writing in her firm’s FDA Law Blog,
Drugs
The CDER Office of Translational Sciences 2023 annual report says it highlights achievements in the areas of drug regulatory review; inspections; science and research; advancing tools, technologies, and innovation; administrative operations; and outreach and communication efforts. Activities discussed in the report include: * promoting scientific collaboration and innovation in drug regulatory
FDA Policy/General
FDA has posted a final guidance entitled “Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.” The document is intended to provide specific guidance for developing, evaluating and applying mass spectrometric methods for confirming residues of an approved new animal drug used in the approved manner. “Methods may
Drugs
Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced legislation to prohibit tianeptine from being marketed to consumers. The Prohibiting Tianeptine and Other Dangerous Products Act would give FDA authority to prohibit the marketing of products such as tianeptine as dietary supplements. A statement issued by Durbin
Devices
Abbott’s Thoratec unit has recalled (Class 1) its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak. A recall notice says there is risk of a “leak path at the seal interface between the left ventricle assist system inflow cannula and the