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FDA
Trump Executive Order Targets Regulations
On one of his first few days on the job, President Donald Trump signed an executive order that would require all government…
FDA’s Meeting on Promotion – Can We Glimpse the Future?
In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding…
Medical Device Parallel Review Program Made Permanent
A few months back, the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services announced they are…
Citizens Petition Challenges FDA’s Off-Label Rule
On February 8, 2017, three organizations called on the United States Food and Drug Administration (FDA) to overhaul a newly…
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 Announces Safety Labeling Changes Program
As reported by Regulatory Focus, the FDA announced the “safety labeling changes” (SLC) program. It will be reportedly…
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FDA Releases Draft Guidance on Manufacturer Communications with Payors,…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…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
FDA Releases Draft Guidance for Industry on Biosimilar Interchangeability
On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating…