Live Breaking News & Updates on Iotechnology amp nanotechnology

Stay informed with the latest breaking news from Iotechnology amp nanotechnology on our comprehensive webpage. Get up-to-the-minute updates on local events, politics, business, entertainment, and more. Our dedicated team of journalists delivers timely and reliable news, ensuring you're always in the know. Discover firsthand accounts, expert analysis, and exclusive interviews, all in one convenient destination. Don't miss a beat — visit our webpage for real-time breaking news in Iotechnology amp nanotechnology and stay connected to the pulse of your community

Quality System Harmonization Is Here, But With Small Benefit To Device Industry - Life Sciences, Biotechnology & Nanotechnology

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...

United-states , Australia , Canada , Japan , Brazil , American , Drug-administration , Health-canada , Device-single-audit-program , American-national-standards-institute , International-organization

FDA Final Rule Harmonizes Medical Device Quality System Regulation With International Standard - Life Sciences, Biotechnology & Nanotechnology

In its latest global regulatory harmonization effort, on Feb. 2, 2024, the FDA published a final rule amending the cGMP requirements for medical devices contained in the QSR...

Japan , Australia , Canada , International-standard , European-union , Drug-administration , Go-to-guide , Quality-system-regulation , Management-system , Quality-management-systems , Cosmetic-act

Governor Josh Shapiro Launches First Statewide Economic Development Strategy In Nearly Two Decades (Podcast) - Economic Analysis

From 2018 to 2022, Pennsylvania was outspent on economic development incentives by neighboring states in both total incentive spending and average deal size. Over the same period...

Canada , United-states , Pennsylvania , Pennsylvanians , Pennsylvanian , Canadian , Luke-bernstein , Josh-shapiro , Rick-siger , Atlantic-clean-hydrogen-hub , Department-of-community , Life-sciences

Safe Harbor Protection: Acadia Pharms., Inc. v. Aurobindo Pharma Ltd. - Patent

In Acadia Pharms., Inc. v. Aurobindo Pharma Ltd., No. 20-985-GBW (D. Del. Dec. 2023), the district court granted Acadia's motion for summary judgment of no invalidity...

Allergan-court , Barr-labs-inc , Aurobindo-pharma-ltd , District-court , Acadia-pharms-inc , Allergan-united-states-inc , Acadia-pharms , Pharma-ltd , Answering-brief , Boehringer-ingelheim , Allergan-united-states

Top 10 Takeaways From FDA's Revised Quality System Requirements For Medical Devices - Life Sciences, Biotechnology & Nanotechnology

On February 2, 2024, the U.S. Food and Drug Administration ("FDA") published a final rule1 to amend the current good manufacturing practice requirements...

United-states , Assurance-program-audits , Drug-administration , Quality-management-system-regulation , Gray-alert , Quality-system-regulation , Federal-food , Cosmetic-act , Medical-device-single-audit , Quality-system-inspection-technique , Mondaq

FDA Issues Final Rule To More Closely Align With ISO 13485 - Life Sciences, Biotechnology & Nanotechnology

On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation...

Standard-organization , Drug-administration , Quality-system-regulation , Medical-devices , Management-system-requirements , Devices-regulation , Mondaq , Fda-issues-final-rule-to-more-closely-align-with-iso-13485 , Food , Rugs , Ealthcare

Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities - Healthcare

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule...

Human-services , Mental-health , Us-department-of-health , Public-health-emergency , Administration-overdose-prevention-strategy , Services-administration , Substance-abuse , Opioid-treatment-programs , Overdose-prevention , Final-rule , Methadone-medication-take-home-doses

Updates On Aflibercept BPCIA Litigation - Life Sciences, Biotechnology & Nanotechnology

On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. ("Regeneron") filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency status conference.

California , United-states , Northern-district , West-virginia , Samsung-bioepis , Celltrion-inc , Amgen , Regeneron-pharmaceuticals-inc , Amgen-inc , Judicial-panel , Us-district-court , Samsung-bioepis-co

FDA Releases Final Guidance On Use Of Digital Health Technologies For Remote Data Acquisition In Clinical Investigations - Healthcare

As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December.

Software-functions , Digital-health-technologies-for-remote-data , Digital-health-technologies , Remote-data , Clinical-investigations , Premarket-submissions , Applying-human-factors , Usability-engineering , Medical-devices , Mondaq , Fda-releases-final-guidance-on-use-of-digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations

CMS Innovation Center Announces Sickle Cell Disease Focus Under Cell And Gene Therapy Access Model - Healthcare

On January 30, the Centers for Medicare & Medicaid Services' (CMS') Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT)...

United-states , Americans , Children-health-insurance-program , Centers-for-medicare-medicaid , Framework-for-health-equity , Department-of-health , Food-drug-administration , Human-services , Innovation-center , Gene-therapy , Access-model