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TXT OMB OKs Info AERs During Influenza Pandemic [54 Words] [ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a FDA collection of information on postmarketing adverse event reporting for medical products/supplements during an influenza pandemic.
05/29/2015
 
 
TXT Appeals Court Requires Namenda IR to Remain on Market [299 Words] [ Price : $8.95]
A just-published opinion from the 2nd Circuit Court of Appeals upholds a 12/2014 district court preliminary injunction requiring Actavis to continue distribution of Namenda (memantine HCl) immediate-release tablets.
05/29/2015
 
 
TXT Info on Drug/Biologic Labeling Sent to OMB [55 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on requirements on content and format of drug and biologic labeling.
05/29/2015
 
 
TXT Comments Sought on Medication Guides [52 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on the requirement of Medications Guides for certain products that pose a serious and significant public health concern.
05/29/2015
 
 
TXT Panels to Discuss Post-Market Reformulated Oxycontin [122 Words] [ Price : $8.95]
Federal Register Notice: FDAís Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products Advisory Committees will meet 7/7-8 to discuss postmarketing studies of reformulated Oxycontin.
05/29/2015
 
 
TXT Petition Seeks HIV Warning on Depo-Provera [137 Words] [ Price : $8.95]
A petition from CUNY School of Public Health asks FDA to require a warning on Pfizerís injectable contraceptive Depo-Provera about the increased risk of HIV infection (AIDS).
05/29/2015
 
 
TXT Jury Orders Boston Scientific to Pay $100 Million in Mesh Case [189 Words] [ Price : $8.95]
A Delaware jury awards $100 million ($25 million in compensatory and $75 million in punitive damages) to Newark resident Deborah Barba after finding Boston Scientific liable for injuries caused by its transvaginal mesh products.
05/29/2015
 
 
TXT Law Firm Petitions FDA on Zeltiq Device for Submental Fat [249 Words] [ Price : $8.95]
The law firm Hunton & Williams petitions FDA asking that it deny any 510(k) for the Zeltiq CoolSculpting System or a similar Zeltiq device for treating submental fat unless such a submission demonstrates the same intended use as any predicate device and is supported by clinical evidence.
05/29/2015
 
 
TXT Donít Inject Dermal Fillers into Facial Blood Vessels: FDA [315 Words] [ Price : $8.95]
An FDA safety communication cautions that unintentional injection of dermal fillers into facial blood vessels can lead to rare but serious adverse events.
05/28/2015
 
 
TXT Guidance on Mutagenic Impurities in Pharmaceuticals [145 Words] [ Price : $8.95]
Federal Register Notice: FDA releases an ICH guidance: M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.
05/28/2015
 
 
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