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TXT FDA Updates Covid Test Info with Omicron [2652 Words] [ Price : $8.95]
FDA adds omicron updates to its Web page on viral mutations and their impact on Covid tests.
12/07/2021
 
 
TXT 2 Antisense Oligonucleotide Drug Guidances [2675 Words] [ Price : $8.95]
FDA issues draft guidances with clinical recommendations and chemistry, manufacturing, and controls recommendations for sponsors developing some antisense oligonucleotide drug products.
12/07/2021
 
 
TXT Products Association Sues FDA Over NAC [2774 Words] [ Price : $8.95]
The Natural Products Association says it is suing to force FDA to stop regulating N-acetyl-L-cysteine.
12/07/2021
 
 
TXT No FDA OK in Effect for Induction Therapies’ Product [2688 Words] [ Price : $8.95]
FDA warns Induction Therapies about marketing its Collagen P.I.N. microneedling product without agency approval.
12/07/2021
 
 
TXT Califf Nomination Heads to Senate HELP Hearing [585 Words] [ Price : $8.95]
The Senate Health, Education, Labor & Pensions Committee announces a 12/14 hearing on the nomination of Robert Califf to be the next FDA commissioner.
12/07/2021
 
 
TXT FDA Inspections Will Adapt to New Strategies: Attorneys [412 Words] [ Price : $8.95]
A Kleinfeld, Kaplan & Becker online post predicts that the prolonged Covid-19 pandemic will likely see the agency “continue to adapt and utilize new strategies for accomplishing oversight activities that were previously conducted primarily through FDA in-person inspections.”
12/07/2021
 
 
TXT 2 ‘Influencers’ Call for Using More RWD in Trials [2774 Words] [ Price : $8.95]
Two MedHealth “influencers” say the health community must find ways to expand the use of real-world data in clinical trials.
12/07/2021
 
 
TXT CBER Cell/Gene Therapy Office Swamped: Director [532 Words] [ Price : $8.95]
CBER Office of Tissues and Advanced Therapies director Wilson Bryan says the office is swamped with new product submissions to the extent that it is considering restructuring and revamping processes to help move products along the regulatory pathways.
12/07/2021
 
 
TXT Hahn Leading Harbinger Health Testing Startup [2684 Words] [ Price : $8.95]
Former FDA commissioner Stephen Hahn is named CEO of Harbinger Health.
12/07/2021
 
 
TXT Mammography Panel Seeks Nonvoting Reps [58 Words] [ Price : $8.95]
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee.
12/06/2021
 
 
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