2 Fda Indications Expert Witnesses Found

Dermatology, Disability Evaluation - Occupational, Work Exposure, Pediatric dermatology, Misdiagnosis, Biologic agent, Immunosuppression, Adverse Reaction, Delayed diagnosis, Melanoma, Skin cancer, Mohs surgery, IMO IME, Opportunistic infection, Sepsis, Off Label Use, FDA boxed warning, DOD Military, Veteran Administration

...Special interest in cases involving injuries, hospitalization, infection, and death due to misuse of dermatologic medications outside of labeled indications, and without regard to FDA boxed warnings. Also interested in injuries and misdiagnosis resulting from a lack of supervision and training of physician extenders in both civilian, DOD, and VA facilities. Over 30 years of experience in military medicine, family medicine, general medicine, occupational medicine, Mohs surgery, and dermatology. Available for IMEs, IMOs, and chart review of both clinic and hospital records.

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

...Draft rationales and responses to agency comments on proposed labeling worldwide, including the FDA. Support development of labeling for multiple products in Phase II, Phase III, and post-market. Scientifically review clinical documents for accuracy, data support, consistency within and across documents, 100% support of product labeling, and compliance to external and company guidelines. Emerged as a US, EU, and global regulatory labeling landscape (i.e., CCDS, USPI, SmPC) expert well-versed in labeling for diverse therapeutic areas. Remain abreast of global regulatory requirements throughout creation and review of labels for vaccines and products to treat everything from hypertension to infectious diseases. Guide labeling, risk management and product safety for diverse therapeutics that prevent and treat diseases among the leading causes of death worldwide....