Drugs
After a 28-year career at FDA, CDER associate Center director for strategic initiatives Theresa Mullin has retired. During her tenure, she also served as assistant commissioner for planning, and director of CDER’s Office of Strategic Programs. In her most recent role, Mullin oversaw areas of strategic interest to
Drugs
FDA has issued updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products. The document, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” describes standardized procedures for requesting, preparing, scheduling, conducting and documenting
Drugs
A central feature of FDA’s new expedited IND pilot program will be a rolling pre-IND submission process. Under the current system, sponsors generally prepare for one formal pre-IND meeting and must decide when they have sufficient information to engage FDA on their development program. Under the pilot,
Drugs
Eli Lilly has filed six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products, escalating the drugmaker’s efforts to shut down what it describes as a growing black market for the investigational medicine. The company says it has also referred more than 200 individuals
Drugs
The Department of Justice says it has reached a deferred prosecution agreement (DPA) with Veloxis Pharmaceuticals under which the company will pay $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions and purchases of Envarsus XR (envarsus), its kidney transplant immunosuppressive drug. A department
Drugs
Aquestive Therapeutics says topline results from new human factors and pharmacokinetic studies of its Anophylm (dibutebinephrine) support its plan to resubmit an NDA for the drug to FDA in the third quarter of this year. A company statement says the tests were conducted in response to an FDA January complete
Drugs
FDA has released the Form FDA-483 issued following a 9/9-9/13/2024 inspection at the MSN Life Sciences Private Limited Unit II active pharmaceutical ingredient (API) manufacturing facility in Chandampet, Telangana, India. The three inspection observations were: * failure to thoroughly investigate critical deviations and/or the failure(
Drugs
Resilient Pharmaceuticals reportedly has resubmitted an NDA for its midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder (PTSD). Resilient (formerly the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and Lykos Therapeutics) resubmitted the application following a 2024 Complete Response Letter (see story), which recommended additional
Devices
An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold. Hamilton Medical says that certain lots of coaxial breathing circuit sets preassembled with
Drugs
FDA has accepted for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1 (STGD1). The agency has set a user fee review action target date of 2/12/2027. The submission was based on data from the Phase 3 DRAGON trial, which demonstrated a statistically
Drugs
An 8/4 petition submitted by a Matthew Arp (no affiliation or organization listed) asks FDA to create a continuation access pathway, not unrestricted shelf access, for adults with a prior albuterol sulfate inhalation aerosol prescription or clinician-diagnosed airway disease. The petition says the nonprescription product would remain subject
Drugs
President Trump has signed an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended and giving parents more flexibility in vaccination decisions. The order calls for routine
Drugs
Tenax Therapeutics is reporting that its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction. In the LEVEL trial, TNX-103 did not meet statistical significance on
Drugs
FDA has issued ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its NDA for ¹⁷⁷Lu-edotreotide (ITM-11), an investigational radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency letter says the submission could not be approved in its current form due to chemistry, manufacturing and controls
Drugs
Abiomed and manufacturing partner Oscor have issued a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after identifying a potential for leakage that could result in serious bleeding, according to an FDA notice. The introducers are intended to provide access for introducing catheters into the
Drugs
Sarah Ibrahim has been appointed CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January. In this role, Ibrahim serves on CDER’s senior leadership team and supports the Center director by providing executive leadership on strategic initiatives that advance CDER’
FDA Policy/General
The Trump administration is considering an executive order addressing vaccines and autism as soon as next week, according to people familiar with the discussions, potentially launching new federal research into whether vaccines play a role in autism despite extensive scientific evidence finding no causal link. The options under consideration include
Drugs
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) have introduced the bipartisan Prescription Information Modernization Act to allow drug makers to distribute prescribing information electronically while retaining the option to receive paper copies. Current laws require prescribing information — including dosing instructions, drug interactions, precautions for pregnant women, pediatric
Devices
FDA is announcing a 9/23 meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to vote on a Grail PMA for the Galleri test. The test is described as a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect
Drugs
Primus Pharmaceuticals has resubmitted a petition to FDA seeking specific actions on ANDAs for a generic form of the company’s Impoyz (clobetasol propionate) 0.025% topical cream, which is indicated for moderate to severe plaque psoriasis. The petition notes the petition was originally submitted in 2020 by Encore Dermatology,
Drugs
FDA has cited Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection conducted in May, according to a just-posted Form 483. The nine-page inspection report contains seven observations covering equipment qualification, complaint investigations, laboratory controls, aseptic processing, contamination controls and
Drugs
FDA is asking small dispensers under the Drug Supply Chain Security Act to complete an assessment that will evaluate their ability to conduct interoperable tracing of product at the package level. An agency announcement (contains a link to the assessment) says FDA encourages dispensers with 25 or fewer full-time