Products
We have worked with every Reviewing Division in Center for Drug Evaluation and Research (CDER) and the Offices of Blood, as well as Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research.
Medical Devices
- Intrauterine devices
- Condoms
- In-vitro diagnostics
- Tampons
- Wound-care products
- Inhalant devices
- Automated cell preparation instrument for histopathologists
Generic Drugs and OTC Drugs
- Albuterol
- Beclomethacin
- Busulfan
- Budesonide
- Doxorubicin
- Propofol
- Tamoxifen
- Tetracyclines
- Triamterene-Hydrochlorothiazide
Ethical Pharmaceuticals
- Cardiovascular/renal
- Oncology
- Neuropharmaceutical
- Anesthetic, critical care and addiction
- Anti-infective
- Anti-viral
- Gastrointestinal/coagulation
- Hematology
- Metabolic/endocrine
- Pulmonary
- Anti-inflammatory, analgesic and dental
- Dermatologic/Ophthalmologic
Biologics and Biotechnology Products
- Antisense oligonucleotides
- Cytokines
- Manufacturing intermediates
- Monoclonal antibodies
- Recombinant proteins
- Therapeutic enzymes
- Therapeutic peptides
- Therapeutic vaccines
- Therapeutic Oligosaccharides