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Mashup Score: 1Drug Safety-related Labeling Changes (SrLC) - 14 day(s) ago
Itali cs For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. Underlines Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in
Source: www.accessdata.fda.govCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 1FDA Drug Shortages - 4 month(s) ago
THIS PAGE IS TEMPORARILY UNDER CONSTRUCTION WHILE ENHANCEMENTS ARE UNDERWAY. Drug shortage data continues to be updated while under construction.
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
Please see the entry in our drug shortages database as well as the “Dear Health Care Provider” letter regarding this action. https://t.co/Enckc6hb1U
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Mashup Score: 13Patients: Ask FDA - 4 month(s) ago
This form is not for industry stakeholders. *To report adverse events that you observe or suspect for human medical products please use the MedWatch reporting form. For problems with the form please email the Patient Affairs Staff at Webform@fda.gov Note: Meetings and responses are not intended to establish binding agreements pertaining to medical product development programs or to discuss proprietary information pertaining to specific development programs under FDA
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
Have a question about a drug, biologic or medical device, ask the FDA by submitting your questions using this online form ⬇️ https://t.co/yXQoPS2n9Y https://t.co/vqG54wrTz3
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Mashup Score: 0Device Classification Under Section 513(f)(2)(De Novo) - 4 month(s) ago
U.S. Food & Drug Administration – New Search Back to Search…
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
On Friday, we granted marketing authorization to the Body Temperature Software App intended to measure the body temperature in people of all ages, excluding premature infants. https://t.co/eJBhpuRwHf
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Mashup Score: 18Interactive Nutrition Facts Label - 5 month(s) ago
The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
Healthy eating is especially important for those living with diabetes. Explore our Interactive Nutrition Facts label to help you or someone you love make informed food choices for a healthy diet. https://t.co/actVOsd8RS #NationalDiabetesAwarenessMonth https://t.co/oR7BLy5wT2
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Mashup Score: 5Premarket Approval (PMA) - 6 month(s) ago
Ablation catheter, renal denervation ReCor Medical, Inc. 1049 Elwell Court Palo Alto, CA 94303 Approval Order Statement The Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
We also approved the first breakthrough designated device intended to treat patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. https://t.co/APmCm94MMl
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Mashup Score: 3510(k) Premarket Notification - 6 month(s) ago
– New Search Back To Search Results Device Classification Name interoperable automated glycemic controller 510(k) Number K232382 Device Name Control-IQ…
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
Finally, we cleared for marketing a software-only device intended for use with compatible integrated continuous glucose monitors (iCGMs) and alternate controller-enabled (ACE) insulin pumps for the management of type 1 diabetes in those 2 years or older. https://t.co/RVbIGUQSUx
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Mashup Score: 0Recognized Consensus Standards: Medical Devices - 6 month(s) ago
12/21/2020 Dental/ ENT 4-268 Complete ANSI ADA Standard No. 32-2017 Orthodontic
Source: www.accessdata.fda.govCategories: General Medicine News, General HCPsTweet-
Also, we announced our recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns: ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers. https://t.co/GZyJ6x7gOy
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Mashup Score: 0Approved Risk Evaluation and Mitigation Strategies (REMS) - 7 month(s) ago
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a d rug or biological product outweigh its risks. The table below provides links to currently approved individual and shared system REMS. Information on historical and released REMS is available in downloadable: data files. Abecma (Idecabtagene vicleucel), suspension, for intravenous infusion BLA #125736 Idecabtagene
Source: www.accessdata.fda.govCategories: Hem/Oncs, Latest HeadlinesTweet-
@BonumCe @Global_CME @ACCCBuzz @umangtalking @JungSongCNS @jaiyesi1 @AlexSpiraMDPhD @killthecancer @KBollinMD @BSantomasso 6/Step 1️⃣Review FDA REMS program 🔗https://t.co/et2DRbxxFl 🔑REMS requirements are met by accreditation w/ @FACTcelltherapy 🔑 #CART (idecabtagene vicleucel & ciltacabtagene autoleucel) are admin'd in a cellular therapy center capable of apheresis #MMsm #MultipleMyeloma https://t.co/O26vQk1xbL
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Mashup Score: 0510(k) Premarket Notification - 9 month(s) ago
– New Search Back To Search Results Device Classification Name alternate controller enabled insulin infusion pump 510(k) Number K213536 Device…
Source: www.accessdata.fda.govCategories: General Medicine News, Latest HeadlinesTweet-
On Tuesday, July 25, we cleared for marketing the DEKA ACE Pump System, an Alternate Controller Enabled insulin pump that delivers insulin under the skin for people 13 years of age and older with diabetes mellitus. https://t.co/I08uTurGiE
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“…recommendation to consider screening for the HLA-B*58:01allele prior to initiating therapy. This is a genetic marker for severe skin reactions indicative of hypersensitivity of #allopurinol. African,Asian,& Native Hawaiian/Pacific Islander ancestry https://t.co/oTfM0TpI1b