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FDA regulation example

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(@efields30)
Posts: 27
Eminent Member
Topic starter
 

The FDA has created many regulation agencies to monitor medical devices, biologics , and drugs.

CDRH: Reviews and approves medical devices

CDER: Reviews and approves prescription, OTC, and generic drugs

CBER – Reviews and approves biologics, donor screening, and blood establishment products 

as quoted from the PowerPoint. Provide three examples of each regulation that would be examined.

 
Posted : 19/03/2022 11:01 pm
(@devdesai)
Posts: 79
Trusted Member
 

As you mentioned, CDRH, which stands for Center for Devices and Radiological Health, reviews and approves medical devices. Three examples of medical devices listed on the CDRH FDA site that were approved in 2022 are SBL-3 Multifocal Intraocular Lens by Lenstec Inc, BioFreedom Drug Coated Coronary Stent System by Biosensors International USA Inc, and AccelStim Bone Growth Stimulator by Orthofix US LLC. 

CDER, which stands for Center for Drug Evaluation and Research, reviews and approves prescription, OTC, and generic drugs. Three examples of drugs listed on the CDER FDA site that were approved in 2022 are Opdualag and Sotyktu by Bristol Myers Squib and Vtama by Dermavant Sciences. 

CBER, which stands for Center for Biologics Evaluation and Research, reviews and approves biologics, donor screening, and blood establishment products. Three examples of biologics listed on the CBER FDA site that were approved in 2022 are Spikevax by Moderna Inc, Carvykti by Jannsen Biotech Inc, and Priorix by GlaxoSmithKline. 

 
Posted : 27/09/2022 4:40 pm
 sg
(@sohinighosal)
Posts: 25
Eminent Member
 

For the Center of Devices and Radiological Health(CDRH) the three devices I looked at were the Implanted Electrical Device Intended For Treatment Of Fecal Incontinence, Alignment Laser Product, and the Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation. The first and last are medical devices that both and premarket approval. The middle device was a radiation emitting product, with its radiation type being optical and it being used for dental ultraviolet products.

For the Center of Drug Evaluation and Research(CDER) the three drugs I looked at were Amantadine, Vumerity, and Zeposia. All three were approved this week, and all three come in capsule format and must be taken orally. With the exception of Zeposia, Amantadine had an extended release while Vumerity had a delayed release.

For the Center of Biologics Evaluation and Research(CBER) the three products I looked at were Fibrinogen Concentrate(RiaSTAP), Dengue Tetravalen Vaccine(DENGVAXIA), and Wasp Venom Protein(Polistes spp). The first is a Blood product that treats acute bleeding episodes in patients with congenital fibrinogen deficiency and was approved as of June 4, 2021. The second is a vaccine for the Dengue disease and only intended for us in ages 9-16, approved as of Januarry 22, 2020. The third is a allergenic product, which is a standardized injectable allergen extract, from Jubilant HollisterStier LLC, titled under ALK Abello A/S.

 
Posted : 30/09/2022 3:38 pm
(@sm2744)
Posts: 78
Trusted Member
 

I was looking at approvals that were granted this year looked further into these:

CDRH - JUVÉDERM VOLUX XC, a gel implant/dermal filler. I've always heard of Juvederm in the media as a celebrity go-to for plastic surgery but I never actually thought about its regulation or uses other than lip fillers! This year, this type of Juvederm was approved to improve jaw definition. The eCoin Peripheral Neurostimulator was also approved and its purpose is to help stimulate nerves in individuals who suffer from urinary incontinence. My last example would be the Organ Care System (OCS) Heart System, a device was originally approved to be used for hearts recovered from donation-after-brain-death donors but this year, was approved to include donation-after-circulatory-death donors.

CDER - 3 drugs that were approved this month by CDER are Skyrizi by AbbVie, Riociguat by MSN, and Opcon-A by Bausch and Lomb. Skyrizi is used to treat moderate-severe plaque psoriasis and Crohn's disease, as well as active psoriatic arthritis. Riociguat is prescribed for patients diagnosed with persistent/recurring chronic thromboembolic pulmonary hypertension. Opcon-A are eyedrops that are currently being sold but their recent approval was for changing their labels on the box!

CBER - 3 biologics that were approved this year were the MicroAire LipoFilter System by MicroAire Surgical Instruments, LLC., NEO Iris by Immucor, Inc., and RegenKit-Wound Gel-2 by RegenLab SA. The MicroAire LipoFilter System is a single use container used during liposuction to collect and store adipose tissue. NEO Iris is a microprocessor-controlled instrument that is used to fully automate in vitro testing of human blood. RegenKit-Wound Gel-2 is classified as a "Peripheral Blood Processing Device For Wound Management" and is primarily used for ulcer treatment by creating a PRP gel from the patient's own blood.

 

The two companies that stood out to me the most were Bausch and Lomb, AbbVie, and Juvederm. What familiar companies did you see in your research or what smaller companies caught your eye?

 
Posted : 01/10/2022 7:42 pm
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