Regulatory tracker
Daily aggregated filings from FDA, DEA, SEC, CMS, and the Federal Register, filtered for mental health relevance.
Major Depressive Disorder (MDD) — Accelerated bilateral dmPFC-iTBS
Post Partum, Maternal Depression, Maternal Depression and Parent Practices, Postpartum — YouMatter
Perinatal Depression, Perinatal Anxiety — The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care
Testicular Cancer — Goal-focused Emotion-regulation Therapy
Stroke (Subacute) — Virtual-reality hypnotherapy device
Sarcoma, Germ Cell Tumor of Testis, Ovarian Tumor, Breast Cancer — HYPNOSIS
Procedural Pain, Anxiety, Tru-Cut Biopsy, Stress Response — Behavioral: Stress Ball Application
Post-Traumatic Stress Disorder — Continuous wearable physiological monitoring (EmbracePlus, Empatica), Ketamine-assisted therapy (independently arranged), Structured pre- and post-session interviews
Smartphone Addiction, Postural Disorders, Dysfunctional Breathing — Observational Assessment
Alcohol Use Disorder — Baseline [C-11]NOP-1A PET scan, Hydrocortisone, Post-hydrocortisone [C-11]NOP-1A PET scan
Schizophrenia — Aticaprant, Placebo
Schizophrenia, Schizo Affective Disorder, Healthy — Placebo, IL-23
Major Depressive Disorder (MDD) — Active Transcranial Temporal Interference Stimulation Targeting Left ALIC, Active Transcranial Temporal Interference Stimulation Targeting Left sgACC, Sham Transcranial Temporal Interference Stimulation
Depression / Major Depressive Disorder, Mental Health (Depression) — Stress Management and Resiliency Training with Qigong/Tai Chi, Healthy Living Program
Suicide Ideation, Depressed — Behavioral Activation
Major Depressive Disorder (MDD) — DT-101, Placebo
Depression, Parkinson's Disease (PD) — Psilocybin (drug), Psilocybin (drug)
Depression - Major Depressive Disorder — High-dose home-tDCS, Conventional home-tDCS
Post Operative Delirium, Cognitive Impairment, Vagus Nerve Stimulation, Depression — Transcutaneous vagal nerve stimulation, Sham (No Treatment)
Depression and Anxiety Symptoms — Loving-Kindness Meditation, Visualization
Major Depressive Disorder — Acupuncture, Sham Acupuncture
Climate Anxiety, Menstrual Product Choice, Environmental Sustainability, Health Behavior — Gain-framed ecological message, Loss-framed ecological message, Neutral informational message
Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure — FD-NIRS and DCS
Depressive Disorder, Secondary, Hematopoietic Stem Cell Transplantation — Xiaochaihu Granules (Low Dose), Xiaochaihu Granules (High Dose)
Perinatal Depression, Perinatal Anxiety — The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care
Anhedonia, Emotional Blunting — Psilocybin, Placebo
Depressive Symptoms, Cognitive Symptom — Baricitinib
Health Anxiety, Quality of Life — self administered questionnaire
Chronic Pain, Poor Sleep Quality, Social Isolation or Loneliness, Sedentary Behaviors, Anxiety Chronic — Online Web-based Health Promotion
Osseodensification Drilling Technique, Dental Implants — Osseodensification techniques, Conventional drilling technique, Osseodensification technique
Hepatocellular Carcinoma, Pancreas Cancer, Biliary Tract Neoplasms — Actigraphy, Online Mindfulness Meditation, Smartphone Application-based Intervention
PTSD - Post Traumatic Stress Disorder, Sexual Abuse — Restory
Internet Addiction Level, Quality of Sleep, Medical Students, Academic Performance
Schizophrenia — cognitive test
Schizophrenia — Risperidone 4 to 6 mg/day, Cognitive Behavioral Therapy
The Drug Enforcement Administration proposes placing diphenidine (1-(1,2-diphenylethyl)piperidine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act.
The Drug Enforcement Administration (DEA) proposes to revoke the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products list but whose National Drug Code (NDC) is inactive because they are no longer availa
Anxiety Symptoms, Depressive Symptoms, Emotion Regulation — Wearable-Based Real-Time Emotional Awareness and Cognitive Reappraisal Training, Retrospective Emotion Journaling and Cognitive Reappraisal Training
Prader-Willi Syndrome — Regulating Together group therapy
Perinatal Anxiety, Perinatal Depression, Maternal Mental Health — Virtual Reality Forest Mindfulness Intervention, Conventional Mindfulness Intervention
Perinatal Depression, Postpartum Depression (PPD) — Parents and Babies
Depression Symptoms — Creativity Camp
Chronic Pain, Kinesiophobia (Fear of Movement) — Virtual Reality-Supported Rehabilitation, Pain Education, Usual Care
Mental Health and General Well-being — Miracle of Mind meditation, Neutral audio learning task
Opioid Use Disorder — Behavioral Activation (BA), Attendance Reinforcement (AR), Peer-Delivered Motivational Interviewing (PDMI)
Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine — Probiotic Formula, Placebo
The Drug Enforcement Administration (DEA) issues this temporary order to schedule 2-(2-fluorophenyl)-2- (methylamino)cyclohexan-1-one (commonly known as 2- fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and salts of isomers whenever the existence of such salts,
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD) — Accelerated Intermittent Theta Burst Stimulation (iTBS)
Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Posttraumatic Stress Disorder (PTSD) — CIDI-5
Dental Anxiety in Children — Regular Piano Training, No Piano Training
Eating Disorders, Eating Disorders Symptoms — Bilateral Stimulation
Breast Surgery — Questionnaires, Video Health Education Materials, Written Health Education Materials
Alzheimer Disease, Dementia, Mild Cognitive Impairment, Peer-bonded Caregiver, Caregiver — Drumming session, Music-listening session
Breast Cancer, Anxiety, Depression — Augmented Reality Health Education Video, Routine Health Education
Smoking Cessation, Smoking Behaviors — Tirzepatide, Placebo
Opioid Use Disorder, Clinical Decision Support — Refined EMBED CDS, Provider alert to order consultation with addiction counselor
Alcohol Use Disorder (AUD) — Alcohol Reduction Counseling, Nutraceutical Treatment, Psychological Intervention
Ketogenic Diet, Alcohol Drinking, Alcohol Use Disorder, Magnetic Resonance Imaging, Alcohol Intoxication — Ketogenic diet
Schizophrenia — Transcranial Sonography
Schizophrenia Spectrum Disorders, Social Cognition — Visual-illusion social cognition session (immediate), Visual-illusion social cognition session (delayed)
The Drug Enforcement Administration (DEA) proposes to revise existing regulations relating to the management of quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA- registered manu
The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 1, 2025, and March 31, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through Mar
Amneal Pharmaceuticals, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Organix Chemistry Solutions, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Breasts - Female, Breast Cancer, Breast Cancer in Women — Pilates Studio Program Group
Pain, Anxiety, Chronic Rhinosinusitis (CRS), Nasal Obstruction, Nasal Polyp, Eustachian Tube Dysfunction, Dysphonia, Subglottic Stenosis (SGS) — Virtual reality headset or goggles
Opioid Use Disorder — Digital Toolkit
HIV Prevention, Substance Use — LYNX, Standard of Care
Depression, Unipolar Depression, Bipolar Depression Depressed Phase — Bright Light Therapy
Addiction — STAR Intervention
Substance Use Disorder (SUD), Addiction, Anxiety, Emotional Dysregulation, Rumination - Thoughts — Residential rehabilitation as usual
Nicotine Use Disoder, Opioid Use Disorder — Sweet-cooling, Sweet non-cooling EC flavor, Tobacco flavor EC
Adolescents With Substance Use Disorder — The Trauma-Informed Sport-Based Intervention Program
Severe Mental Illness, Substance Use Disorder (SUD) — Clinical Pharmacist Intervention
Benuvia Operations, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors, Smoking Cessation, Smoking Dependence, Smoking Addiction, Smoking Cessation Intervention, Smoking E-cigarette, Smoking Abstinence — Telemedicine-Based Smoking Cessation Program, Conventional Smoking Cessation B
PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals, Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia, Hyperlipidemia (E.G., Hypercholesterolemia) — Colesevelam, Placebo
Alcohol Use Disorder (AUD) — Multiple Errand Test (MET), Virtual MET
Substance Use Disorder (SUD) — continuing care app
Major Depressive Disorder — Motif XCS System
Schizophrenia / Schizoaffective Disorder — NST-SPARK
Schizophrenia, Bipolar Disorder, Criminal Behavior — R-FACT intervention, Standard Outpatient Treatment
SCHIZOPHRENIA 1 (Disorder), Schizoaffecitve Disorder — EEG Neurofeedback
Treatment Resistant Disorders — Medtronic Percept with SensSight Deep Brain Stimulation System
Internet Gaming Disorder, Internet Addiction — Clinical Evaluation and Biochemical Sampling
Problematic Media Use, Parent-Child Relational Problem, Screen Media Use — screen addiction training
Substance Abuse Disorder, Addiction, Clinical Stratification, Substance-related Disorders, Residential Treatment Program — No intervention (observational only)
Substance Use Disorder (SUD), Anxiety, Depression Anxiety Disorder — No intervention
Bipolar Disorder (BD) — Temporal Interference Stimulation, Sham Temporal Interference Stimulation Arm Description
Substance Use Disorder (SUD), Treatment Adherence — Ecological Momentary Assessment (EMA)
Opioid Abuse (Disorder) — Adapted Multi-Dimensional Family Therapy, Specialty Treatment Court Program Services
Opioid Abuse (Disorder), Stimulant Use Disorders — Patient Navigation
Severe Mental Illness, Depression / Major Depressive Disorder, Bipolar Disorder (BD), Schizophrenia — Semaglutide (SEMA), Exercise module, Anti-inflammatory diet module
SCHIZOPHRENIA 1 (Disorder), Substance Abuse
With the issuance of this final rule, the Drug Enforcement Administration places 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3- b]indol-1-one (other names: CUMYL-PEGACLONE; SGT-151), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, an
Tobacco-Related Carcinoma, Addiction — Biospecimen Collection, Nicotine, 6-Methyl Nicotine
Alcohol Use Disorder — Sequential Prefrontal Alpha-Theta Neurofeedback Training
Schizophrenia — KR23248, Matching Placebo
Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period — Structured Postnatal Debriefing
Substance Use Disorder (SUD) — Engagement Strategy 1, Engagement Strategy 2, Engagement Strategy 3
Psychoeducation Study — Structured Psychoeducation Program
Posttraumatic Stress Disorder (PTSD), Borderline Personality Disorder (BPD) — Group Written Exposure Therapy
Schizophrenia Patients, Neuroinflammation — Risperidone 4mg/day, Ashwagandha, Placebo
Addiction — Assessment
Behavior, Addictive, College Student — Semistructured interview
Alcohol Use Disorder, Alcohol Use Disorder (AUD) — STAR
Bipolar Disorder (BD), Healthy Control — This is an observational study with no intervention.
Post Traumatic Stress Disorder — MDMA
PTSD - Post Traumatic Stress Disorder, PTSD, PTSD Symptoms, PTSD, Post Traumatic Stress Disorder — COMP360 psilocybin
Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder, Treatment-resistant Bipolar Depression, Major Depressive Disorder (MDD), Bipolar Disorder (BD), Bipolar Disorder I or II, Suicidal Ideation — Ketamine Hydrochloride, Midazolam Hydrochloride, Dia
Schizophrenia — KarXT (xanomeline and trospium)
Schizophrenia Spectrum & Other Psychotic Disorders — REFLECT: REFlecting on and Learning to Evaluate Core beliefs in real Time
Bipolar Disorder — Ketogenic foodstuffs, Standard of Care Oral antipsychotics, Standard of care long acting injectable medication for bipolar disorder
Psychological Trauma — Transcranial Magnetic Stimulation (TMS), TMS Sham
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6H- benzo[c]chromen-1-ol (also known as hexahydrocannabinol, and HHC) in schedule I of the Con
Patheon API Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
ANI Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
PTSD and Trauma-related Symptoms — Preparatory Session, Ketamine-assisted Psychotherapy Session #1, Ketamine-assisted Psychotherapy Session #2
Posttraumatic Stress Disorder (PTSD) — Prolonged exposure and EMDR
4-STEP-Training Program for Social Media Addiction — 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)
Cigarette Addiction, Tobacco Use Disorder — Biospecimen Collection, Questionnaire Administration, Cigarette Purchase Task
Treatment Resistant Depression (TRD) — Psychedelic Integration Coaching
Negative Symptoms of Schizophrenia — Roluperidone, risperidone, aripiprazole
With the issuance of this final rule, the Drug Enforcement Administration places methyl 2-[[1-(4-fluorobutyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA), N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1- yl)-1H-indazole-3-ca
Post Traumatic Stress Disorder, Post Partum Depression, Acute Stress Symptoms — Postpartum Psychological Screening
Lower Urinary Track Symptoms, Benign Prostate Obstruction (BPO) — Transurethral resection of the prostate., Bipolar enucleation of the prostate
10-K/A
Anxiety, PTSD — Electrical stimulation device, Electrical stimulation device
Non-communicable Diseases (NCD), Addiction to Opioids, Incarceration, Opioid-use Disorders
SCHIZOPHRENIA 1 (Disorder) — repetitive transcranial magnetic stimulation (rTMS)
Digital Screen Addiction and Sleep Quality in Adolescents — Digital Detox Intervention
Schizophrenia — Gamified Digital Rehabilitation
Psychotic Disorders, Hallucinations, Auditory, Social Isolation — Veteran Voices and Visions (VVV), Wellness Recovery Action Planning (WRAP)
Schizophrenia — Somatic Serious Games
Bipolar Disorder, Substance Use (Drugs, Alcohol) — Senyo Health App
Bipolar Disorder (BD) — Flow FL-100 tDCS headset