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TXT Product-specific Draft Bioquivalence Guides [64 Words] [ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence studies to support ANDAs.
11/08/2021
 
 
TXT MedWatch Info Collection Extension [73 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “MedWatch: The FDA Medical Products Reporting Program.”
11/08/2021
 
 
TXT House Probes FDA/McKinsey Conflicts of Interest [414 Words] [ Price : $8.95]
The House Oversight and Reform Committee requests information on FDA’s consulting contracts with McKinsey due to potential conflicts with consulting company’s role in advising opioid maker Purdue while also advising FDA on its regulatory actions involving the drugs.
11/08/2021
 
 
TXT Animal Drug Regs Amended for Application Actions [76 Words] [ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug and abbreviated new animal drug applications during April, May, and June.
11/08/2021
 
 
TXT Woodcock Upbeat on Generic/Biosimilar Programs [536 Words] [ Price : $8.95]
FDA acting commissioner Janet Woodcock says there continues to be huge opportunities for growth in the generic and biosimilar space.
11/08/2021
 
 
TXT Eton/Azurity NDA Approved for Eprontia [92 Words] [ Price : $8.95]
FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for treating certain seizures.
11/08/2021
 
 
TXT Magstim 510(k) for Brain Stimulator Cleared [137 Words] [ Price : $8.95]
FDA clears a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation device designed for the clinical setting.
11/08/2021
 
 
TXT Info Collection Revision on Drug Reporting [117 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products.”
11/05/2021
 
 
TXT Animal Drug Approval Docs Available [80 Words] [ Price : $8.95]
Federal Register notice: FDA amends the animal drug regulations to reflect recent application-related actions for new animal drug applications and abbreviated new animal drug applications.
11/05/2021
 
 
TXT 7-Item 483 Issued to ACRX Specialty [97 Words] [ Price : $8.95]
FDA issues a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after finding GMP problems during an inspection in July.
11/05/2021
 
 
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