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A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.

Hilary-marston , Patrizia-cavazzoni , Sarah-yim , Drug-administration , Association-of-accessible-medicines , New-drug-office , Therapeutic-biologics , Chief-medical-officer , Drug-evaluation , Biologics-price-competition , Innovation-act , Accessible-medicines

FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
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China , United-states , Pmrs-pmcs , Patrizia-cavazzoni , Sarah-yim , Hilary-marston , Human-services , Office-of-media-affairs , Accelerator-applications-united-states-inc , Day-one-biopharmaceuticals-inc , Us-department-of-health , Cardinal-health

First over-the-counter birth control pill, Opill, now sold in-store at HEB, other retailers

First over-the-counter birth control pill, Opill, now sold in-store at HEB, other retailers
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San-antonio , Texas , United-states , Olmos-park , Patrizia-cavazzoni , Walmart , Food-drug-administration , Walgreens , Drug-administration , Drug-evaluation , While-opill ,

Supreme Court opens discussion about the abortion drug mifepristone

Supreme Court opens discussion about the abortion drug mifepristone
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United-states , American , Wesley-tingey-unsplash , Yuchacz-wikipedia , Janet-woodcock , Robert-califf , Xavier-becerra , Patrizia-cavazzoni , Family-research-council , National-association-of-pro , Alliance-for-hippocratic-medicine , Human-services

Monoclonal Antibody Pemgarda Authorized as COVID Protection for At-Risk Groups

Monoclonal Antibody Pemgarda Authorized as COVID Protection for At-Risk Groups
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Massachusetts , United-states , Cameronr-wolfe , Patrizia-cavazzoni , Dave-hering , Drug-administration , Duke-university-school-of-medicine , Duke-university-school , Drug-evaluation ,

FDA and OHRP publish draft guidance on facilitating understanding in informed consent | Hogan Lovells

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research...

Patrizia-cavazzoni , Hogan-lovells , Hilary-marston , Research-our , Federal-policy , Human-subjects , Common-rule , Institutional-review , Review-boards , Cooperative-research , Medical-officer-hilary-marston ,

FDA Gathers Public Social Media Data To Better Understand Cannabis Users As Part Of Its Effort Toward Rescheduling Marijuana

For six months, social scientists immersed themselves in a detailed analysis of online and social media conversations around cannabis.

Patrizia-cavazzoni , Anne-milgram , Office-of-surveillance , Drug-administration , Controlled-substances , Controlled-substances-act , Drug-safety-priorities , Drug-evaluation , Ongoing-struggle-for , Earl-blumenauer ,

FDA Hosts Public Psychedelics Discussion, Discloses Major Growth On Number Of New Psychiatric Drugs Filings Post-2000 - Johnson & Johnson (NYSE:JNJ), Mind Medicine (NASDAQ:MNMD)

FDA and Reagan-Udall Foundation are hosting a virtual public meeting on psychedelic research titled Advancing Psychedelic Clinical Study Design, which aims to explore empirical approaches to address issues in drug development.

Michael-bogenschutz , Tiffanyr-farchione , Michael-davis , Patrizia-cavazzoni , Carla-canuso , Robert-barrow , Johnson-jnjdr , Johns-hopkins-university , Veterans-administration , Federation-of-state-medical-boards , Neuroscience-office , Udall-foundation

CDC NOTES: CDC, FDA expedite availability of RSV immunization for infants

In November, the CDC announced the release of more than 77,000 additional doses of Beyfortus™ (nirsevimab-alip (100 mg), a long-acting monoclonal antibody…

Alaska , United-states , America , American , Niravd-shah , Patrizia-cavazzoni , Vaccines-for-children-program , American-college-of-obstetricians , Children-program , Drug-evaluation , American-college , American-indian

FDA Roundup: January 12, 2024

FDA Roundup: January 12, 2024
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Massachusetts , United-states , Patrizia-cavazzoni , National-institute-of-standards , Office-of-media-affairs , Veterans-health-administration , Veterans-cardiac-health , Drug-administration , Intershell-international-corp , Drug-research , Digital-health-center , Digital-health-collaboration-fosters-innovation