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TXT Indivior Exec Pleads Guilty in Suboxone Film Case [2632 Words] [ Price : $8.95]
The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of introducing misbranded Subxone Film into interstate commerce.
09/01/2020
 
 
TXT Nitrosamine Control Guidance Out [2705 Words] [ Price : $8.95]
FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs.
09/01/2020
 
 
TXT Hahn Should Tell Truth or Resign: Topol [466 Words] [ Price : $8.95]
Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to hold a press conference and tell the truth about how he was pressured to misrepresent the effectiveness of convalescent plasma or resign.
09/01/2020
 
 
TXT Don’t Let Orange Book Block Competition: 23 AGs [2671 Words] [ Price : $8.95]
Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book as a way to speed generic competition.
09/01/2020
 
 
TXT Regulatory Review Period for Lumoxiti [108 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharma’s Lumoxiti.
09/01/2020
 
 
TXT Info Collection on Biologic Adverse Experience Reporting [92 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Adverse Experience Reporting For Licensed Biological Products; and General Records—21 CFR Part 600.”
09/01/2020
 
 
TXT Guide on Device Patient-reported Outcomes Usage [113 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.
08/31/2020
 
 
TXT OMB Approves Eight Information Collections [148 Words] [ Price : $8.95]
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.
08/31/2020
 
 
TXT FDA Releases Draft Bioequivalence ANDA Guides [54 Words] [ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs.
08/31/2020
 
 
TXT FDA Approves Innocoll NDA for Xaracoll [198 Words] [ Price : $8.95]
FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.
08/31/2020
 
 
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