Sarah Blankstein

Promotional Compliance

• Routinely review promotional materials for pharmaceutical and medical device companies for both FDA and FTC compliance.
• Conducted a comprehensive risk assessment of a large pharmaceutical company’s speaker programs.
• Advised a medical device company in its response to an FTC investigation of the company’s promotional practices, resulting in a public closing letter.

Regulatory Approvals and Lifecycle Management

• Advised a biotechnology company throughout the BLA process, including in connection with eligibility for priority review, the advisory committee process, and dispute resolution mechanisms.
• Regularly advise clients on Hatch-Waxman issues related to patents, including eligibility of patents for Orange Book listing, completion of FDA Form 3542 and development of “use codes,” and considerations related to patent certifications, Section viii carve-outs, and patent listing disputes.
• Drafted successful request for a rare pediatric disease priority review voucher on behalf of a pharmaceutical client.
• Provided strategic advice to a large pharmaceutical company seeking to amend a pediatric written request (PWR) to obtain pediatric exclusivity.
• Counseled a major medical device company on numerous 510(k) submissions and labeling updates.
• Counseled a medical device company on regulatory approval strategy for an over-the-counter device, including assisting with preparation for and participating in a formal pre-submission meeting with the FDA review division.

Transactional and Litigation Support

• Performed regulatory diligence and negotiated key regulatory deal terms in numerous corporate transactions involving pharmaceutical and medical device companies.
• Partnered with litigation teams on government investigations of pharmaceutical and device companies involving alleged FDCA violations.
• Assisted a medical device company with a large internal investigation related to recall and regulatory reporting decisions.
• Advised pharmaceutical company in connection with investigation of data integrity allegations involving preclinical studies for a pipeline product.

General Regulatory

• Advised pharmaceutical companies on GCP requirements, including informed consent and IRB requirements, as well as IND safety reporting.
• Routinely provide strategic advice and analysis to digital health clients on evolving FDA regulatory framework for software products and artificial intelligence technologies.
• Conducted a comprehensive assessment of a major pharmaceutical company’s clinical trial data sharing policies to support compliance with the PhRMA/EFPIA joint Principles for Responsible Clinical Trial Data Sharing.
• Drafted and reviewed policies and procedures for a range of pharmaceutical and medical device clients, including policies governing promotional activities and interactions with healthcare providers, scientific communications, clinical trials, grants and sponsorships, investigator initiated research, sampling, GxP and quality activities, and adverse event reporting.
• Advised pharmaceutical manufacturers, medical device companies, and compounding pharmacies during regulatory inspections and in responding to FDA 483s.
• Advised a pharmaceutical company in connection with REMS modifications and implementation.
• Counseled a biotechnology company on a range of issues related to clinical trial transparency, including clinicaltrials.gov requirements, clinical trial data sharing, and lay summaries.