Ehrreich Consulting - Consultants for FDA Approval of Drugs, Devices, and Biomaterials


Ehrreich Consulting Project Table 

This is a table of recent projects, 2000-2005, and is not exhaustive.

Product Type

Product Name

Description of Use or EC Involvement

Date

Combination Drug Albuterol / Ipratropium bromide Nebulized and inhaled to treat COPD 9/12/2000
Drug Aptosyn Familial Polyposis 9/1/2000
Blood Pressure Drug Name Confidential Treats high blood pressure in type II diabetes - fraud case 6/3/2000
Dermatologic Drug Acne Contract 5/20/2003
Drugs ANDAs (atenolol, lisinopril, nabumetone) Sought out top selling generics to "piggy back" 6/19/2003
Alternative Therapy Piso-electric Acupuncture 510(k) 7/20/2004
Anti-anxiety Drug Name Confidential Multi-state conference call w/ Assistant State Attorneys General, review materials, track issues 8/26/2002
Lipid-lowering Drug Name Confidential Statin; lowers cholesterol - reviewed MOR, protocols, clinical reports, for law firm 1/9/2003
Product Evaluation herpes drug Analyze investment opportunities based on review of documents 4/14/2003
Crohn's disease Drug   Inflammatory Bowel Disease (aka Crohn's) 8/30/2001
Neutraceutical CBBC (Chinese Black-Boned Chicken) Extract   11/27/2001
Antidote Chemical weapons antidote   2/4/2003
Food Contact Substance Bamboo cutting board Chinese-made, evaluate laminating glue testing 3/31/2004
Food Product Diet Chocolate, tea, coffee French diet chocolate - advise as to animal testing, import 6/17/2004
Neuro-Oncological Drug Dibromodulcitol (DBD) Anti-cancer agent used in cerebral tumors (medulloblastoma), cervical cancer, IND - FDA meeting 10/10/2000
Dietary Supplements Jaraprin, New S-Fidus - imported from Korea General well-being - we helped clear the packaging & labeling through FDA hold 2/27/2001
Depilatory Cream Depilatory Cream Italian depilatory cream 7/15/2003
Food Contact Substance Diamond coating for pill presses, meat cutters Diamond machines - review materials, dept. agriculture 2/11/2004
Enhancement, Female Sexual Theophylline Cream Wrote advice memo 9/17/2001
Homeopathic   Weight loss 12/3/2002
Class II Devices Self-hypnosis Tapes Evaluation of Class II Devices 12/4/2003
Pulmonary Combination Drug Ipratropium bromide / Albuterol Nebulized and inhaled to treat COPD 9/12/2000
Drug & Device Combination Iontophoretic Device and Minoxidil Analog Topical minoxidil tartrate applied for hair loss, aided by iontophoresis 11/14/2000
Topical Drug 10% Gel Non-Steroidal Anti-Inflammatory applied for muscle soreness 11/5/2001
Iontophoretic Device Iontophoretic Device Contract 5/5/2003
Infrared Device IR Muscle Heating Device Cleared FDA inspection 5/19/2004
Device Ion Generator Increases Metabolic Rate 7/22/2004
NSAID Drug Ketoprofen with linool Enhanced topical non-steroidal anti-inflammatory cream 12/10/2001
Metabolic/Endocrine Drug Levothyroxine Oral tablets to treat hypothyroidism, NDA 10/10/2000
Drug Limonene Crohn's disease 11/25/2002
Device Table Chiropractic power traction table - 510(k) 3/3/2003
Food Item Throat Lozenges Import / export forms, labeling 11/13/2003
  Biotherapies Monoclonal Antibody   6/11/2001
Anti-Cancer Drug Methotrexate Leukemia, breast cancer, MS, arthritis, non-surgical abortions (by blocking folic acid) 11/7/2001
Anti-Cancer Drug Modrastane Orphan Product Designation (OPD) 1/30/2002
Medical Marker Medical Pen Marker A medical skin-marking pen containing 12 disposable cartridges of gentian violet dye 7/30/2003
Cosmetic MicroAlgae Saxitoxin / epomer Faster healing & cheaper than botox - Chile 8/11/2003
Medical Food Medical Food Diabetic medical food 2/12/2004
Device Electrodes Disposable, sterile subdermal needle electrodes applied to EEG, EMG, nerve conduction and stimulation / response 2/28/2004
Food Product Raw Milk Labeling 6/15/2004
Nicotine (2mg) Teabag Nicotine (2mg) Teabag Citric acid combined with nicotine & tea leaves to brew a drink 4/29/2002
Spray Drug Nicotine Spray Nicotine Nasal Spray Approval Documents  
Orphan Grants DBD 11/5/2001
  Oregano Oil Pills   12/17/2003
Household Cleaner Polyhexanide Domestic Indoor Cleaner 6/20/2001
Periodontal Diagnostic Microarray Diagnostic Evaluate anin vitro diagnostic system for periodontitis 7/14/2003
Biomaterial Injectable Peptide Toxicity expert 7/18/2003
PE & Psoriasis Drug Drug for PE & Psoriasis NDA for premature ejaculation in Dutch studies, additional indication for dermatology 12/5/2003
Dermatologic Drug Compound from eggs Atopic dermatitis, chemistry concerns 1/14/2004
Pregnancy Device Basal Body Temperate (BBT) Ovulation tool Uses well-known algorithms to pinpoint ovulation 5/20/2004
Injection Device Retractable Syringes General Purpose, IDU & Insulin - fully retractable & self-disabling syringes 7/25/2002
Weight Loss Drug Skinny Pill for kids Weight loss for children - toxicity issue 12/12/2002
Tanning Spray Dihydroxyacetone Self-tanning - evaluated for safety 7/10/2003
Anesthetic Drug & Delivery System Nasal spray Anesthetic for surgery 3/24/2004
Device Ultraviolet (UV) - Germany We worked with Consumer Product Safety Commission & Registration kit for EPA (many applications) 6/14/2001
Drug Analgesic agent OA & Pain - litigation assistance 4/2/2003
Drug Patented new drug ACE Inhibitor - legal assistance 10/12/2004
Drug Weight Loss Reviewed materials & provided global plan w/ costs 11/8/2002
Antidepressant Drug New agent Antidepressant - evaluate legal issues 12/12/2002
Purifier Device Water purifier for pools   3/17/2004

 

Contact Ehrreich Consulting: 15640 Greenock Lane, SE - Fort Myers, FL 33912
 Phone: (239) 561-2110 | Mobile: (239) 910-2200 | Fax: (239) 561-2009

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