New Drug Regulatory Program Modernization

Judit Milstein
Chief, Project Management Staff
Division of Ophthalmology
Acting Director of Project Management Staff
Office of Specialty Medicine
Office of Regulatory Operations
[email protected]

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 New Drug Regulatory Program Modernization
▪ Better serve patients
▪ Better support staff in their work to carry out the Center’s mission
▪ Problem-focused, interdisciplinary, team based approaches
▪ Meet challenges of evolving science, new drug platforms, new drug
targets while incorporating patients voice in development
• https://www.fda.gov/drugs/regulatory-science-research-and-education/reorganization-office-new-
drugs-corresponding-changes-office-translational-sciences-and-office
– https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder

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 New Drug Regulatory Program Modernization
Programs and Projects
▪ Integrated Review for Drug Marketing Applications
▪ IND Review Management
▪ Postmarket Safety Management
▪ Assessing and Developing Talent
▪ Administrative Operations
▪ Transition Management and Reorganization of the New Drugs
Regulatory Program
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 Office of New Drugs
Director: Peter Stein, MD
Deputy Director: Mary Thanh Hai, MD (acting)

▪ Clinical Offices
– 8 Offices
– 27 Clinical Divisions
– 6 Divisions of Pharmacology/Toxicology
▪ Office of Regulatory Operations (ORO)
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs

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Clinical Offices and Divisions Names
Office of Regulatory
Operation: Divisions of
Regulatory Operations

Office of Rare
Office of Cardiology,
Office of Office of Diseases, Pediatrics,
Office of Infectious Office of Oncologic Office of Hematology, Office of Specialty
Nonprescription Immunology and Urologic and
Diseases (OID) Diseases (OOD) Neuroscience (ON) Endocrinology and Medicine (OSM)
Drugs (ONPD)1 Inflammation (OII) Reproductive
Nephrology (OCHEN)
Medicine (ORPURM)

Division of Division of Division of

Division of Division of Division of Division of
Division of Anti- Nonprescription Rheumatology and Pediatrics and
Oncology I Neurology I Cardiology and Ophthalmology
infectives (DAI) Drugs I Transplant Maternal Health
(DO I) (DN I) Nephrology (DCN) (DO)
(DNPD I) Medicine (DRTM) (DPMH)

Division of Division of Pulmo- Div. of Rare

Division of Division of Division of Division of Imaging
Division of Nonprescription nology, Allergy, Diseases and
Oncology II Neurology II Non-Malignant and Radiation
Antivirals (DAV) Drugs II and Critical Care Medical Genetics
(DO II) (DN II) Hematology (DNH) Medicine (DIRM)
(DNPD II) (DPACC) (DRDMG)

Division of Division of Urology,

Div. Of Pharm/Tox Division of
Division of Diabetes, Lipid Division of Gastro- Obstetrics, and
for Infectious Oncology III
Psychiatry (DP) Disorders, and enterology (DG) Gynecology
Diseases (DPT-ID) (DO III)
Obesity (DDLO) (DUOG)

Division of Div. of Anesthesio- Div. of Pharm/Tox

Division of General Division of
Hematologic logy, Addiction of Rare Diseases,
Endocrinology Hepatology and
Malignancies I Medicine, and Pain Pediatrics, Urologic
(DGE) Nutrition (DHN)
(DHM I) Medicine (DAAP) and Reproductive
Medicine (DPT-
Division of Division of Div. of Pharm/Tox RPURM)2
for Cardiology, Division of Shared P/T
Hematologic Pharm/Tox for
Malignancies II Neuroscience Hematology, Dermatology and support to
Dentistry (DDD)
(DHM II) (DPT-N) Endocrinology, and OSM
Nephrology (DRO-
CHEN) Div. of Pharm/Tox
Division of Heme /
for Immunoogy and
Onc Toxicology
Inflammation (DPT-
(DHOT)
II)

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 Office of Regulatory Operations (ORO)
▪ Director: Jennifer Mercier (Acting)
▪ Deputy Director: Jacqueline Ware, PharmD (Acting)

▪ 8 Divisions of Regulatory Operations aligned with the

corresponding clinical offices
–Director of Project Management Staff
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 Office of Infectious Diseases
Director: John Farley, MD, MPH
Deputy Director: Adam Sherwat, MD (Acting)

▪ Division of Anti-Infectives
▪ Division of Antivirals
▪ ORO-DRO-ID-Director of Project Management Staff: Maureen
Dillon-Parker (Acting)

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 Division of Anti-Infectives (DAI)

– Director: Sumathi Nambiar, MD, MPH

– Deputy Director: Dmitry Iarikov, MD, PhD
– ORO-Chief Project Management Staff:
• Maureen Dillon Parker
• Carmen DeBellas, PharmD, RPh
Antibacterial, antifungal, antimycobacterial, most antiprotozoal and sepsis
drug products

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 Division of Antivirals (DAV)

• Director: Debra Birnkrant, MD

• Deputy Director: Jeffery Murray, MD, MPH
• ORO-Chief Project Management Staff;
• Karen Winestock
• Linda Akunne, MPH (Acting)
Antiviral drugs

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 Office of Oncologic Diseases
Director: Richard Pazdur, MD
Deputy Director: Marc Theoret, MD (Acting)
▪ Division of Oncology 1 (DO1)
▪ Division of Oncology 2 (DO2)
▪ Division of Oncology 3 (DO3)
▪ Division of Hematologic Malignancies 1(DHM1)
▪ Division of Hematologic Malignancies 2 (DHM2)
▪ ORO-DRO-OD-Director of Project Management Staff: Melanie
Pierce

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 Division of Oncology 1

▪ Director-Julia A. Beaver, MD
▪ Deputy Director: Amna Ibrahim, MD
▪ ORO-Chief Project Management Staff:
– Christy Cottrell, BS
– Rajesh Venugopal, MPH, MBA (Acting)
Breast, gynecologic, and genitourinary cancers as well as
supportive care (non-hematologic) products
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 Division of Oncology 2

▪ Director-Harpeet Singh, MD
▪ Deputy Director: vacant
▪ ORO-Chief Project Management Staff: Missiratch (Mimi) Biable,
MS (Acting)
Thoracic Head and Neck, Neuro-oncology, rare cancers, pediatric
solid tumors

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 Division of Oncology 3

▪ Director: Steven Lemery, MD (Acting)

▪ Deputy Director: Lola Fashoyin-Aje, MD (Acting)
▪ ORO-Chief Project Management Staff: Norma Griffin, BS (Acting)
Gastrointestinal, superficial cutaneous cancers, melanoma and
sarcoma

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 Division of Hematologic Malignancies 1 (DHM1)

▪ Director: Angelo DeClaro, MD

▪ Deputy Director: Vacant
▪ ORO-Chief Project Management Staff: Amy Baird
Acute Leukemia and Myelodysplasia and Chronic Myeloid Leukemia

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 Division of Hematologic Malignancies 2 (DHM2)

▪ Director: Nicole Gormley, MD

▪ Deputy Director: Vacant
▪ ORO-Chief Project Management Staff: Theresa Carioti, MPH
Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma and
other plasma cell malignancies

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 Office of Non Prescription Drugs
Director: Theresa Michelle, MD (Acting)
Deputy Director: Karen Mahoney, MD (Acting)

• Division of Nonprescription Drugs 1 (DNPD1)

• Division of Nonprescription Drugs 2 (DNPD2)
• ORO-DRO-NPD-Director of Project Management Staff: Celia
Peacock, RDN, MPH, CAPT USPH (Acting)

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 Division of Non Prescription Drugs 1 (DNPD 1)

▪ Director: Karen Mahoney, MD (Acting)

▪ Deputy Director: Nushin Todd, MD
▪ ORO-Chief Project Management Staff: Dan Brum, PharmD, MBA,
CAPT USPHS
Anesthesiology, Addiction and Pain Medicine, Dermatology,
Gastroenterology, Neurology, Pulmonary, Allergy and Critical Care
and Psychiatry
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 Division of Non Prescription Drugs 2 (DNPD 2)

▪ Director: Francis Becker, MD (Acting)

▪ Deputy Director: Vacant
▪ ORO-Chief Project Management Staff: Elizabeth Thompson,
(Selected)
Anti-Infectives, Antivirals, Cardiology and Nephrology, Dentistry,
Diabetes, Lipid Disorders and Obesity, Ophthalmology, Otic,
Urology, Obstetrics and Gynecology
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 Office of Neuroscience
Director: Billy Dunn, MD (Acting)
Deputy Director: Eric Bastings (Acting)

▪ Division of Neurology 1
▪ Division of Neurology 2
▪ Division of Psychiatry
▪ Division of Anesthesiology, Addiction Medicine and Pain Medicine
▪ ORO-DRO-ON-Director of Project Management Staff: Paul David, RPh
(Acting)

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 Division of Neurology 1
▪ Director: Eric Bastings, MD (Acting)
▪ Deputy Director: Therese Buracchio, MD (Acting)
▪ ORO-Chief Project Management Staff: Heather Bullock, RN, BSN,
MSHS (Acting)
Neurodegenerative Disorders, movement disorders, neuromuscular
disorders

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 Division of Neurology 2
▪ Director: Nick Kozauer, MD (Acting)
▪ Deputy Director: Paul Lee, MD (Acting)
▪ ORO-Chief Project Management Staff: Jacqueline Ware, PharmD
Treatment of seizures, epilepsies, medical countermeasures,
migraine, other headaches, traumatic brain injury, inner ear
disorders, stroke and neuroimmunologic disorders (e.g Multiple
Sclerosis)
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 Division of Psychiatry
▪ Director: Tiffany Farchione, MD (Acting)
▪ Deputy Director: Bernie Fisher, MD (Acting)
▪ ORO-Chief Project Management Staff:
– Hiren Patel, PharmD, MS, CDR USPHS (Acting)
– Keith Kiedrow, PharmD, MS, CAPT USPHS (Acting)
Psychiatric diseases and conditions

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 Division of Anesthesiology, Addiction Medicine and Pain
Medicine (DAAP)
▪ Director: Rigoberto Roca, MD (Acting)
▪ Deputy Director: Naomi Lowy, MD (Acting)
▪ ORO-Chief Project Management Staff:
– Matthew Sullivan, MS
– Swati Pathwardan (Acting)
Acute pain, chronic pain, addiction products, surgical, procedural or
ICU settings
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Office of Cardiology, Hematology, Endocrinology and Nephrology
(OCHEN)
Director: Ellis F. Unger, MD
Deputy Director: Mary Thanh Hai, MD

▪ Division of Cardiology and Nephrology (DCN)

▪ Division of Non-malignant Hematology (DNH)
▪ Division of Diabetes, Lipid Disorders and Obesity (DDLO)
▪ Division of General Endocrinology (DGE)
▪ ORO-DRO-CHEN-Director of Project Management Staff: Julie van der
Waag, MPH (Acting)
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 Division of Cardiovascular and Nephrology
▪ Director: Norman Stockbridge, MD
▪ Deputy Director: Aliza Thompson, MD
▪ ORO-Chief Project Management Staff: Edward Fromm, RPh

Cardiovascular conditions and diseases, kidney conditions and

diseases

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 Division of Nonmalignant Hematology (DNH)
▪ Director: Ann Farrell, MD
▪ Deputy Director: Albert Deisseroth, MD, PhD
▪ ORO-Chief Project Management Staff: Charlene Wheeler, MSHS
(Acting)
Clotting disorders (deep venous thrombosis/pulmonary embolism),
abnormalities of red cells (anemia, sickle cell disease), white cells, and
platelets (ITP), bone marrow failure disorders (aplastic anemia), and some
supportive care products for use with chemotherapy and bone marrow
transplantation (stem cell mobilization).

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 Division of Diabetes, Lipid Disorders and Obesity (DDLO)
▪ Director: Lisa Yanoff, MD
▪ Deputy Director: Vacant
▪ ORO-Chief Project Management Staff:
– Callie Capel-Lynch, PharmD (Acting)
– Liz Goodwin, MSHS (Acting)

Type 1 and Type 2 diabetes mellitus, weight loss and weight management,
geriatric frailty and sarcopenia, Lipodystrophy, Vasopressins (central diabetes
insipidus, nocturnal enuresis, Vitamin Deficiency (except Vitamin D)

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 Division of General Endocrinology (DGE)

▪ Director: Theresa Kehoe, MD (Acting)

▪ Deputy Director: Vacant
▪ ORO-Chief Project Management Staff: Elisabeth Hanan, MS (Selected)

Growth Hormone related conditions, adrenal and ACTH disorders,

anabolic steroids, cachexia, hypo- and hypertyroidism,
hyperparathyroidism, Cushing’s syndrome, developmental disorders,
geriatric frailty and sarcopenia

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 Office of Immunology and Inflammation (OII)
Director: Julie Beitz, MD
Deputy Director: Victor Crentsil, MD (Acting)

▪ Division of Dermatology and Dentistry (DDD)

▪ Division of Gastroenterology (DG)
▪ Division of Hepatology and Nutrition (DHN)
▪ Division of Pulmonology, Allergy and Critical Care (DPACC)
▪ Division of Rheumatology and Transplant Medicine (DRTM)
▪ ORO-DRO-II-Director of Project Management Staff: Renmeet Grewal, PharmD,
MS, CDR USPHS (Acting)

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 Division of Dermatology and Dentistry (DDD)
▪ Director: Kendall Marcus, MD
▪ Deputy Director: Shari Targum, MD (Acting)
▪ ORO-Chief Project Management Staff: Barbara Gould

Acne, actinic keratosis, aesthetic indications, atopic dermatitis,

condyloma acuminate, dental caries, gingivitis, psoriasis, rosacea,
superficial basal cell carcinoma, wound healing/ulcers, xerostomia

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 Division of Gastroenterology (DG)
▪ Director: Jessica J. Lee, MD (acting)
▪ Deputy Director: Juli Tomaino, MD, MS
▪ ORO-Chief Project Management Staff: Richard Whitehead, MS (Acting)

Inflammatory bowel conditions, gastroesophageal reflux diseases,

duodenal/gastric ulcers, celiac disease, eosinophilic gastrointestinal disorders,
motility disorders, constipation, bowel cleansing agents, anorectal disorders,
anti-diarrheal agents, anti-emetics, pancreatic agents

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 Division of Hepatology and Nutrition (DHN)
▪ Director: Joseph Toerner, MD (Acting)
▪ Deputy Director: Frank Anania, MD
▪ ORO-Chief Project Management Staff: Ayana Augustus Bryant, PhD

Liver diseases and nutritional disorders

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 Division of Pulmonary, Allergy and Critical Care (DPACC)
▪ Director: Sally Seymour, MD
▪ Deputy Director: Banu Karimi-Shah, MD
▪ ORO-Chief Project Management Staff: Ladan Jafari

Asthma, Chronic Obstructive Pulmonary Disease, Allergic Rhinitis,

Cough and Cold symptoms (RX drug products), Anaphylaxis, Cystic
Fibrosis, Product for critical care (epinephrine), surfactants for infant
respiratory distress syndrome

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Division of Rheumatology and Transplant Medicine (DRTM)

▪ Director: Nikolay Nikolov, MD (Acting)

▪ Deputy Director: Ozlem Belen, MD, MPH (Acting)
▪ ORO-Chief Project Management Staff: Sandra (Sandy) Barnes
Rheumatological conditions and solid organ transplantation
rejection medicines

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 Office of Rare Diseases, Pediatrics, Urologic and
Reproductive Medicine (ORPURM)
Director: Hylton Joffe, MD (Acting)
Deputy Director: vacant
▪ Division of Rare Diseases and Medical Genetics (DRDMG)
▪ Division of Pediatric and Maternal Health (DPMH)
▪ Division of Urology, Obstetrics and Gynecology (DUOG)
▪ ORO-DRO-RPURM-Director of Project Management Staff: Pamela
Lucarelli (Acting)

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Division of Rare Diseases and Medical Genetics (DRDMG)

▪ Director: Kathleen (Katie) Donohue, MD (acting)

▪ Deputy Director: Patroula Smpokou, MD (acting)
▪ ORO-Chief, Project Management Staff: Matthew White, PhD
Aminoacid Metabolism Disorders, Lipoprotein Metabolism
Disorders, Organic Acid Disorders, Lysosomal Storage Diseases,
Mitochondrial Disorders

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 Division of Pediatric and Maternal Health (DPMH)
▪ Director: Lynne Yao, MD
▪ Deputy Director: John Alexander, MD, MPH
▪ ORO-Chief, Project Management Staff
– Rosemary Addy, MHS
– George Greely, MS, MBA (Acting)
Internal processes and guidance in support of PREA (Pediatric Research
Equity Act), BPCA (Best Pharmaceuticals Childrens’ Act)

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 Division of Urology, Obstetrics, and Gynecology (DUOG)

▪ Director: Christine Nguyen, MD (acting)

▪ Deputy Director: Audrey Gassman, MD
▪ ORO-Chief Project Management Staff:
– Margaret (Margie) Kober, RPh, MPA
– Samantha Bell, BS, BA (Acting)
Prevention or treatment of reproductive and urologic conditions

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 Office of Specialty Medicine
Director: Charles Ganley, MD (acting)
Deputy Director: Alex Gorovets, MD (acting)

▪ Division of Imaging and Radiation Medicine (DIRM)

▪ Division of Ophthalmology (DO)
▪ ORO-DRO-SM-Director of Project Management Staff: Judit
Milstein (Acting)

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Division of Imaging and Radiation Medicine (DIRM)
▪ Director: Libero (Lou) Marzella, MD (acting)
▪ Deputy Director: vacant
▪ ORO-Chief Project Management staff: Kyong (Kaye) Kang
Image-base diagnosis and monitoring of diseases, radiology,
nuclear medicine, products used in the treatment of injury caused
by radiation or radioactive materials

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 Division of Ophthalmology (DO)
▪ Director: Wiley A. Chambers, MD (acting)
▪ Deputy Director: vacant
▪ ORO-Chief Project Management Staff:
– Diana Willard, BS

Ophthalmic products used in the diagnosis, management and treatment

of ocular diseases, otic products except those indicated for otitis media.

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