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Gland Pharma Ltd updates on US FDA Inspection at Dundigal Facility, Hyderabad

Gland Pharma Ltd has announced about the Pre-Market Inspection covering US FDA's Quality System / Current Good Manufacturing Practice regulations for Medical Devices i.e., 21 CFR Part 820 at Dundigal Facility at Hyderabad.

Dundigal , Tamil-nadu , India , Hyderabad , Andhra-pradesh , Office-of-product-evaluation , Gland-pharma-ltd , Radiological-health , Company-dundigal-facility-at-hyderabad , Gland-pharma , Quality-center

USFDA concludes inspection at Gland Pharma's Hyderabad facility

It has received the Establishment Inspection Report (EIR).

Office-of-product-evaluation , Radiological-health , Gland-pharma , Quality-center , Gland-pharma-limited , Current-good , Dundigal-facility , Establishment-inspection-report , Product-evaluation ,

FDA User Fee Programs Reauthorized FDA's CBER Is A Clear Winner

Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the...

Nancy-bradish-myers , Peter-marks , Rick-pazdur , Oncology-center , Office-of-plasma-therapy , Pharmaceuticals-for-children , Catalyst-healthcare-consulting-inc , Office-of-review-management , A-new-super-office , Office-of-gene-therapy , Office-of-digital-health , Office-of-product-evaluation

FDA User Fee Programs Reauthorized FDA's CBER Is A Clear Winner

Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the...

Nancy-bradish-myers , Peter-marks , Rick-pazdur , Oncology-center , Office-of-plasma-therapy , Pharmaceuticals-for-children , Catalyst-healthcare-consulting-inc , Office-of-review-management , A-new-super-office , Office-of-gene-therapy , Office-of-digital-health , Office-of-product-evaluation

Backlog of vaccine injury claims persists as reform languishes

The two federal programs intended to compensate people injured by vaccines or pandemic countermeasures are fielding thousands of claims unlikely to be resolved — or paid out — anytime soon.

Oregon , United-states , Ghana , Ghanaian , Chuck-grassleyr-iowa , Marsha-blackburnr-tenn , Jeff-shuren , Maggie-hassan , Usha-lee-mcfarling , David-lim , Kurt-schrader , Erin-banco

Holland & Knight Health Dose: May 3, 2022 - Healthcare

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.

Louisiana , United-states , White-house , District-of-columbia , Ukraine , Gabriella-miller , Drug-administration , Commerce-committee , User-fee-agreements-other-health-priorities , Revamps-office-of-product-evaluation , Pfizer , Office-of-product-evaluation

FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies | King & Spalding

During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use...

William-maisel , Jeff-shuren , Office-of-product-evaluation , Radiological-health , Department-of-health , Human-services , Drug-administration , Agency-enforcement-policies , Public-health-emergency , Emergency-use-authorizations , Enforcement-policies , Draft-guidance

FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

Healthcare

William-maisel , Ed-margerrison , Office-of-product-evaluation , Radiological-health , Office-of-science , Dive-brief , Product-evaluation , Engineering-laboratories , Additive-orthopaedics , Hospitals , Hospital-administration , Government

FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use

/PRNewswire/ -- Today, the U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety. "At the...

William-maisel , Audra-harrison , Office-of-product-evaluation , Radiological-health , Health-care-providers , Drug-administration , Product-evaluation , Plastic-surgery-devices-panel , Medical-devices-advisory-committee , Us-food-and-drug-administration ,

FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use

/PRNewswire/ -- Today, the U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety. "At the...

William-maisel , Audra-harrison , Office-of-product-evaluation , Radiological-health , Health-care-providers , Drug-administration , Product-evaluation , Plastic-surgery-devices-panel , Medical-devices-advisory-committee , Us-food-and-drug-administration ,