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FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule
$249.00
Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval. Read More
Drugs
CDER’s Priorities for 2022: What You Must Know About New Guidance and Program Plans – Webinar Recording/Transcript
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Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules – Webinar Recording/Transcript
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Proving Comparability in Cell and Gene Therapy Development: Untangling FDA Requirements
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Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
$287.00
Prepare Your Drug/Biologics Facility for the New FDA Inspection Model: Will It Be Remote, In-Person or Hybrid? – Webinar Recording/Transcript
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FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan
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Supply Chain Solutions: How the Pharmaceutical Industry Can End In-Bound Issue – Webinar Recording/Transcript
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Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript
$287.00