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TXT Some Mole Products Can Injure, Scar: FDA [164 Words] [ Price : $8.95]
FDA cautions consumers not to use products marketed as mole or skin tag removers.
06/09/2022
 
 
TXT Foundation Medicine Companion Diagnostic Approved [207 Words] [ Price : $8.95]
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indications for Genentech’s of Rozlytrek (entrectinib).
06/09/2022
 
 
TXT Concerns on Drug Quality Metrics Proposal Aired [379 Words] [ Price : $8.95]
Four additional stakeholders raise concerns about the FDA quality metrics proposal.
06/09/2022
 
 
TXT 5 Observations on BPI Labs FDA-483 [170 Words] [ Price : $8.95]
FDA releases the FDA-483 with five observations issued following a 2021 inspection at Largo, FL-based BPI Labs.
06/09/2022
 
 
TXT Cruz, Others Question FDA on Covid-19 Vaccines for Babies [748 Words] [ Price : $8.95]
Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age 5.
06/09/2022
 
 
TXT Consider New Approach to Monitor Drug Quality [263 Words] [ Price : $8.95]
University of Kentucky researchers say FDA should consider moving to an alternate approach to monitoring drug quality rather than relying on current good manufacturing practice inspections.
06/09/2022
 
 
TXT Last Minute Manufacturing Data Delays Novavax Vaccine [201 Words] [ Price : $8.95]
FDA delays making a decision on Novavax’s Covid-19 vaccine emergency use authorization request after the company submitted last minute manufacturing data that the agency must review.
06/09/2022
 
 
TXT End ‘Patent Thickets’: Senators [205 Words] [ Price : $8.95]
A bipartisan group of six senators calls on the U.S. Patent and Trademark Office to change its policies and procedures to eliminate so-called patent thickets.
06/09/2022
 
 
TXT FDA Accepts Few Labeling Changes for Propecia [2876 Words] [ Price : $8.95]
FDA orders some Propecia labeling changes sought in a 2017 petition and denies most of the other changes sought.
06/09/2022
 
 
TXT House Passes User Fee/FDA Amendments Bill [631 Words] [ Price : $8.95]
The U.S. House of Representatives votes 392 to 28 to pass the Food and Drug Amendments of 2022), which would reauthorize FDA user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices, while also including provisions to enhance the accelerated approval program and boost FDA inspections.
06/09/2022
 
 
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