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FDA Withdraws 216 ANDAs
Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines including blanket no-change certification (BNCC) or establishment registration (ER).
Overview of Pharma Annual Deadlines and Requirements
Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to...
Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations
The FDA has proposed new changes to the regulations regarding over-the-counter sunscreen products. Perhaps the most...
Medical Device Classifications in Global Markets and Health Authorities
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements...
FDA GUDID Class I Reminder
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID?...
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...