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FDA
OPDP Picks Up Steam on Enforcement Letters
After a fairly slow 2016, the United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP)…
CDER 2017 Guidance Agenda
In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and…
A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the…
Dr. Janet Woodcock on the Opioid Epidemic
The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the…
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…