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TXT ‘Intended Use’ at Root of FDA 1st Amendment Issues: Attorney [2850 Words] [ Price : $8.95]
Attorney Jeffrey Shapiro says it isn’t known what the Trump administration will do with FDA’s controversial intended use final rule that is now scheduled to take effect 3/21.
02/21/2017
 
 
TXT Latest FDA Warning Letters [162 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that cites Fenwal Inc. and Humco Holding Group.
02/21/2017
 
 
TXT Docket Established for Pediatric Postmarketing Reviews [1149 Words] [ Price : $8.95]
Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between 9/17/2016 and 2/24/2017 on the agency’s Web site.
02/21/2017
 
 
TXT New ‘Patent Dance’ Suit Filed Over Avastin [2708 Words] [ Price : $8.95]
Genentech asks a court to declare that Amgen is violating BPCIA patent dance provisions by failing to provide additional manufacturing information in addition to its Avastin aBLA.
02/21/2017
 
 
TXT Multiple Violations at Humco Holding Group [2961 Words] [ Price : $8.95]
FDA’s Dallas District Office warns Humco Holdings about CGMP and other violations in its manufacturing of finished pharmaceuticals.
02/21/2017
 
 
TXT Momenta Glatopa Fill/Finish Contractor Warned [2636 Words] [ Price : $8.95]
Momenta says approval of its ANDA for Glatopa 40 mg will likely be delayed due to an FDA Warning Letter issued to a contract Pfizer fill/finish facility.
02/21/2017
 
 
TXT Securities Suits Continue Against Life Sciences Companies: Attorneys [2833 Words] [ Price : $8.95]
Four Dechert attorneys write in a white paper that life sciences companies remain an easy target for securities class action lawsuits and should take steps to protect themselves.
02/21/2017
 
 
TXT Petition Asks Potassium Chloride Actions [5316 Words] [ Price : $8.95]
Vertice asks FDA to require elemental metals testing and controls in any NDA or ANDA for potassium chloride oral drug products.
02/21/2017
 
 
TXT FDA Priority Review for Pfizer Leukemia BLA [198 Words] [ Price : $8.95]
FDA accepts for priority review a Pfizer BLA for inotuzumab ozogamicin for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
02/21/2017
 
 
TXT Gilead Bags Priority Review Voucher from Sarepta for $125 Million [126 Words] [ Price : $8.95]
Sarepta Therapeutics enters into an agreement to sell to Gilead its FDA Rare Pediatric Disease Priority Review Voucher for $125 million.
02/21/2017
 
 
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