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Technology News- BioPharm News
- Shire Gains European Approval for its Gaucher Disease Treatment
- Mtech Bioprocess Scale-Up Facility to Double in Staff and Size
- ImClone Closes Plant in New Jersey, Consolidating Erbitux Manufacture
- EMA and FDA Seek Applicants for Joint GMP Inspections
- ATMI Expands Bloomington, Minnesota Manufacturing Facility
- Clinical Trials News
- CRF Health Achieves EXACT ePRO Vendor Certification for Windows Mobile Systems
- ACR Image Metrix Establishes Global Presence
- BioPharm Systems Named to the 2010 Inc. 500|5000 List of Fastest-Growing Companies in the U.S.
- CRF Health Doubles North American Headquarters
- Oracle Completes Acquisition of Phase Forward
Tag Archives: U.S. Food and Drug Administration
Feds Chase Down Faulty Skincare Promos
FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims.
J&J received a violation letter in response to a journal ad for its [...]
Posted in FDA, Marketing Also tagged Advertising, Allergan, Clinical trial, Johnson & Johnson 1 Comment
FDA Readies More Warning Letters, Fast Enforcement Action
Image by Getty Images via Daylife
FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many [...]
Posted in FDA Also tagged business, FDA, Food and Drug Administration, Food safety, Hamburg, Margaret Hamburg, United States Leave a comment
Adverse Event Reports Go Digital Only
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FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions.
“This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
Posted in Regulatory, Safety Also tagged Adverse event, Center for Drug Evaluation and Research, Drug Evaluation and Research, FDA, pharmaceutical industry 1 Comment
Lilly Osteoporosis Drug Canned in Phase III Trials
Image by go elsewhere… via Flickr
Lilly, on Wednesday, announced that it would not seek regulatory approval for its osteoporosis treatment arzoxifene, because the drug failed to meet certain end points in Phase III clinical trials.
The good news is that the drug was successful in meeting the primary end point of the trial, dubbed “GENERATIONS.†[...]
Posted in Strategy Also tagged arzoxifene, Breast cancer, Clinical trial, GENERATIONS, Lilly, Osteoporosis drug market Leave a comment
Pfizer Settles Whistleblower Case for $2.3 Billion