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TXT Janssen’s Invokamet Approved for New Indication [1181 Words] [ Price : $8.95]
FDA approves a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.
TXT Groups Fear Weakened REMS [2956 Words] [ Price : $8.95]
The 16 member organizations of the Patients’ Alliance for Drug Safety Protections caution that proposed legislation could weaken FDA drug safety and REMS.
TXT Armenpharm ANDA Withdrawn for Safety/Effectiveness [1120 Words] [ Price : $8.95]
Federal Register Notice: FDA suspends approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous versions of chloramphenicol were withdrawn from sale for reasons of safety or effectiveness.
TXT False Advertising Claim Not Precluded by FFDCA [2912 Words] [ Price : $8.95]
The 2nd Circuit Appeals Court says that the fact that FDA cleared a home pregnancy test with specific instructions on how it is to be marketed does not preclude a competitor from bringing a false advertising claim under the Lanham Act.
TXT Heidelberg Engineering 510(k) Clearance for Glaucoma Module [1242 Words] [ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provide a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics.
TXT FDA Accepts TherapeuticsMD NDA for Yuvvexy [1187 Words] [ Price : $8.95]
FDA accepts for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse.
TXT Latest FDA Warning Letters [1414 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Option Care Enterprises, Jeffreys Drug Store, Sarkli/Repechage and ZO Skin Health Group.
TXT FDA Draft Guide on Determining When REMS is Necessary [1400 Words] [ Price : $8.95]
FDA posts a draft guidance on “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.”
TXT Coordinated Antimicrobial Drug, Test Development Guidance [2707 Words] [ Price : $8.95]
FDA solicits comment on a draft guidance to assist drug sponsors and medical device manufacturers who want to coordinate development of new antimicrobial drugs and antimicrobial susceptibility test devices.
TXT Computational Modeling Studies Reporting Guidance [2734 Words] [ Price : $8.95]
FDA issues a guidance on reporting formats for medical device computational modeling and simulation studies.
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