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Guidelines
FDA Releases Draft Guidance for Industry: Statistical Approaches to…
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft…
Chicago’s Attempt to Regulate Drug Reps – A Real Public Health…
Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has…
Chicago Releases Draft Rules on Industry Representative Licensure
In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of…
FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and…
Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to…
FDA Extends Wait for Biosimilar Interchangeability Guidance
The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime…
FDA Releases Draft Guidance on Manufacturer Communications with Payors,…
In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled “Drug and Device…
Final Common Rule – Sixteen Agencies Update Regulations on…
The Department of Health and Human Services (HHS), along with fifteen other federal agencies, issued a final rule updating…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
New Rule and Guidance Issued on Clinical Trials
Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly…