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TXT Comments Sought on Health Risk Concerns Sent to CDRH [48 Words] [ Price : $7.95]
Federal Register Notice: FDA seeks comments on information submitted to CDRH on health risk concerns about a device or radiological products.
05/07/2013
 
 
TXT Conference on Pharmaceutical Quality Systems [85 Words] [ Price : $7.95]
Federal Register Notice: FDA and the International Society of Pharmaceutical Engineering will co-sponsor a conference on a culture of quality in the pharmaceutical quality system.
05/07/2013
 
 
TXT Latest FDA Warning Letters [731 Words] [ Price : $7.95]
In its latest batch of Warning Letters, FDA cites Coral Rock Man, Glottal Enterprises, Hillestad Pharmaceuticals USA, Medicamat, Musculoskeletal Transplant Foundation, and Natural Medicine AssociatesSunset Natural Products.
05/07/2013
 
 
TXT Companies Improving Cancer Drug Development Process [284 Words] [ Price : $7.95]
A Tufts Center for the Study of Drug Development analysis shows that companies are succeeding in becoming more efficient in studying potential cancer drugs.
05/07/2013
 
 
TXT Judge to Rule on FDA Plan B Stay Request This Week [374 Words] [ Price : $7.95]
New York federal judge Edward Korman says he will rule by the end of the week on FDA’s request to stay his order last month that the agency lift age restrictions on all levonorgestrel-based emergency contraceptives.
05/07/2013
 
 
TXT 70% of Doctors Want DTC Ads Scaled-back or Eliminated [172 Words] [ Price : $7.95]
A CMI/Compas survey of 104 doctors finds that nearly three-fourths believe that DTC advertising should be scaled-back or eliminated.
05/07/2013
 
 
TXT Multiple HCT/P Regulation Violations at Olympia [476 Words] [ Price : $7.95]
FDA’s Seattle District Office warns Olympia Womens Health about many violations of HCT/P regulations.
05/07/2013
 
 
TXT Office of Pharmaceutical Science Coordinating Committee MAPP Out [99 Words] [ Price : $7.95]
CDER issues a MAPP on the work of the Office of Pharmaceutical Science Coordinating Committee.
05/07/2013
 
 
TXT FDA Grants AbbVie Breakthrough Therapy Designation [238 Words] [ Price : $7.95]
FDA grants AbbVie a breakthrough therapy designation for its investigational direct-acting antiviral combination with and without ribavirin for treating genotype 1 hepatitis C virus infection.
05/06/2013
 
 
TXT FDA Safety Alert on Anti-seizure Drugs and Pregnancy Use [274 Words] [ Price : $7.95]
A new FDA drug safety alert says the anti-seizure drug valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for preventing migraine headaches.
05/06/2013
 
 
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