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TXT Baxter Bone Graft Cleared [138 Words] [ Price : $8.95]
FDA clears a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and help achieve fusion.
07/09/2020
 
 
TXT Info Collection on Opioid Abuse Deterrent Formulations [100 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB a new information collection entitled “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).”
07/09/2020
 
 
TXT Court Says it Can Hear Paragraph IV Conversion Case [2784 Words] [ Price : $8.95]
Two Gibbons attorneys say the Delaware federal court has ruled that it has subject matter jurisdiction in a generic drug patent case even if the defendants converted their ANDA from a Paragraph IV certification to a Paragraph III certification.
07/08/2020
 
 
TXT Study of Disclosures to Physicians on Unapproved Uses [205 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on a proposed information collection entitled “Study of Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.”
07/08/2020
 
 
TXT CGMP, Other Issues at Washington Homeopathic [2839 Words] [ Price : $8.95]
FDA warns Washington Homeopathic Products about CGMP violations in its manufacturing of unapproved new drugs.
07/08/2020
 
 
TXT Biogen Completes Alzheimer’s Treatment BLA [2684 Words] [ Price : $8.95]
Biogen says it has filed a BLA with FDA for aducanumab to reduce the clinical decline of Alzheimer’s disease.
07/08/2020
 
 
TXT Ionogen Selling Unapproved Covid Drug: FDA [2688 Words] [ Price : $8.95]
FDA warns Ionogen that its Ionopure Skin & Hands product that the company is marketing to treat Covid-19 is a misbranded unapproved new drug that cannot be legally marketed in the U.S.
07/08/2020
 
 
TXT FDA Posts Interim Essure Study Results [2779 Words] [ Price : $8.95]
FDA releases statistics from an Essure follow-up study showing that patients experienced more issues than those who had laparoscopic tubal ligation.
07/08/2020
 
 
TXT Mylan Recalls 1 Daptomycin Lot [70 Words] [ Price : $8.95]
Mylan recalls one lot of daptomycin for injection, 500 mg/vial, due to particulate matter found in one single-dose vial.
07/08/2020
 
 
TXT Study of Multiple Indications in DTC Ads [107 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on a proposed information collection entitled “Study of Multiple Indications in Direct- to-Consumer Television Advertisements.”
07/08/2020
 
 
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