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Drug and Biologic Regulation
Fish & Richardson advises companies and research institutions at all stages of the product development process for new drugs and biologics. Our clients include companies on the cutting edge of technology, such as stem cell research, gene therapy, and tissue engineering. We have experience in all stages of design, development, and marketing of drugs and biologics including the following:
- obtaining "orphan" designations drugs and biologics under the Orphan Drug Act;
- aiding clients in developing legal documents for clinical investigator agreements and informed patient consents;
- advising clients on importing and exporting drugs and product withdrawals; and advising on labeling and promotional issues occurring before and after review by regulatory agencies.
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