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MedWatch Safety Alerts RSS Feed

  • Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

    FDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms [ Read more ]

  • E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

    Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults [ Read more ]

  • Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

    MedWatch Alert on certain prescription insomnia medicines. [ Read more ]
FDA Press Releases RSS Feed

  • FDA approves first treatment for chronic rhinosinusitis with nasal polyps

    FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity. [ Read more ]

  • Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

    FDA is issuing two new draft guidances on drug labeling, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format and Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic [ Read more ]

  • FDA approves first generics of Lyrica

    FDA approves first generics of Lyrica (pregabalin) [ Read more ]

  • FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

    FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations. [ Read more ]

  • FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign

    FDA is launching its first youth e-cigarette prevention TV ads and is planning to provide new educational resources as agency approaches one-year anniversary of public education campaign. [ Read more ]

  • FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

    FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. [ Read more ]

  • Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions

    A federal court ordered an Arkansas company to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. [ Read more ]

  • FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

    FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. [ Read more ]

  • FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

    “Remove the Risk” to raise awareness about proper disposal of prescription opioids [ Read more ]

  • FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations

    FDA suspends facility registration of Texas-based seafood producer [ Read more ]

  • Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

    Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects [ Read more ]

  • FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

    FDA warns patients and providers that certain Medtronic MiniMed insulin pumps are recalled due to potential cybersecurity risks and recommends patients switch to models better equipped to protect against these potential risks. [ Read more ]

  • FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections

    FDA approved Recarbrio, an antibacterial drug to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). [ Read more ]

  • FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

    This press release highlights an update on the FDA’s investigation into a potential connection between certain diets and cases of canine heart disease [ Read more ]

  • Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

    FDA issues statement on actions to tackle youth vaping epidemic and court ruling on application deadlines for certain tobacco products, including e-cigarettes [ Read more ]
Twitter Search / FDADeviceInfo
Twitter feed for: FDADeviceInfo. Generated by TwitRSS.me

  • REMINDER https://twitter.com/FDADeviceInfo/status/1150810724081590272 …

    REMINDER https://twitter.com/FDADeviceInfo/status/1150810724081590272 … [ Read more ]

  • The @US_FDA has updated the Recognized Consensus Standards Database: https://go.usa.gov/xypBh 

    The @US_FDA has updated the Recognized Consensus Standards Database: https://go.usa.gov/xypBh  [ Read more ]

  • On Thursday August 22nd, the @US_FDA will host a webinar on the Final Guidance for the marketing clearance of diagnostic ultrasound systems and transducers. Find out more about the upcoming webinar: https://go.usa.gov/xypB2  #FDA #MedicalDevicepic.twitter.com/aZYsJVUYPI

    On Thursday August 22nd, the @US_FDA will host a webinar on the Final Guidance for the marketing clearance of diagnostic ultrasound systems and transducers. Find out more about the upcoming webinar: https://go.usa.gov/xypB2  #FDA #MedicalDevice pic.twitter.com/aZYsJVUYPI [ Read more ]

  • Today, the @US_FDA issued the Draft Guidance: Emergency Use Authorization of Medical Products and Related Authorities. Submit comments by August 19, 2019. Find out more about the guidance and how to submit comments: https://go.usa.gov/xypK6  #FDA #MedicalDevicepic.twitter.com/q92tHFQLlR

    Today, the @US_FDA issued the Draft Guidance: Emergency Use Authorization of Medical Products and Related Authorities. Submit comments by August 19, 2019. Find out more about the guidance and how to submit comments: https://go.usa.gov/xypK6  #FDA #MedicalDevice pic.twitter.com/q92tHFQLlR [ Read more ]

  • Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Infusion Sets for the Alaris Pump Model 8100 due to potential for tube collapse that may cause issues with medication delivery https://go.usa.gov/xypDT  #MedicalDevicepic.twitter.com/9bLlPV6YPe

    Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Infusion Sets for the Alaris Pump Model 8100 due to potential for tube collapse that may cause issues with medication delivery https://go.usa.gov/xypDT  #MedicalDevice pic.twitter.com/9bLlPV6YPe [ Read more ]

  • Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Pump Module Model 8100 Bezel Assembly. https://go.usa.gov/xypjG  #FDA #MedicalDevicepic.twitter.com/g9WQnodfNt

    Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Pump Module Model 8100 Bezel Assembly. https://go.usa.gov/xypjG  #FDA #MedicalDevice pic.twitter.com/g9WQnodfNt [ Read more ]

  • On July 17th, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks- https://go.usa.gov/xypjr  #FDA #MedicalDevicepic.twitter.com/EUaOIHvIA2

    On July 17th, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks- https://go.usa.gov/xypjr  #FDA #MedicalDevice pic.twitter.com/EUaOIHvIA2 [ Read more ]

  • #DYK July 12th was #NationalDifferentColoredEyesDay?! Be informed about eye safety if you wear contact lenses and check out the @US_FDA's information on everyday eye care. https://go.usa.gov/xyp37 pic.twitter.com/hzuvuX4Ylc

    #DYK July 12th was #NationalDifferentColoredEyesDay?! Be informed about eye safety if you wear contact lenses and check out the @US_FDA's information on everyday eye care. https://go.usa.gov/xyp37  pic.twitter.com/hzuvuX4Ylc [ Read more ]

  • The @US_FDA’s Software #FDAPreCert Program for #DigitalHealth is committed to a collaborative and transparent development process. Learn about the program’s progress, including relevant findings and outcomes of the testing so far. https://go.usa.gov/xyVJW  #MedicalDevicepic.twitter.com/p9eOKqyQYy

    The @US_FDA’s Software #FDAPreCert Program for #DigitalHealth is committed to a collaborative and transparent development process. Learn about the program’s progress, including relevant findings and outcomes of the testing so far. https://go.usa.gov/xyVJW  #MedicalDevice pic.twitter.com/p9eOKqyQYy [ Read more ]

  • To help health care providers better understand risks associated with CSF shunt valves and magnetic field interference from implanted hearing devices, the @US_FDA issued a Letter to Health Care Providers with recommendations. Read more: https://go.usa.gov/xymb6  #MedicalDevicepic.twitter.com/XVMmwAOgeH

    To help health care providers better understand risks associated with CSF shunt valves and magnetic field interference from implanted hearing devices, the @US_FDA issued a Letter to Health Care Providers with recommendations. Read more: https://go.usa.gov/xymb6  #MedicalDevice pic.twitter.com/XVMmwAOgeH [ Read more ]

  • REMINDER https://twitter.com/FDADeviceInfo/status/1149800062723268608 …

    REMINDER https://twitter.com/FDADeviceInfo/status/1149800062723268608 … [ Read more ]

  • The @US_FDA will accept submissions from July 15, 2019, through Oct. 15, 2019, and intends to announce the selected applicants in December 2019. https://go.usa.gov/xyPJR  #FDAInnovationChallenge

    The @US_FDA will accept submissions from July 15, 2019, through Oct. 15, 2019, and intends to announce the selected applicants in December 2019. https://go.usa.gov/xyPJR  #FDAInnovationChallenge [ Read more ]

  • On August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the challenges. https://go.usa.gov/xyPJG pic.twitter.com/XKPcX6GgcB

    On August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the challenges. https://go.usa.gov/xyPJG  pic.twitter.com/XKPcX6GgcB [ Read more ]

  • The @US_FDA hopes that these challenges will result in new sterilization methods or reduce emissions from ethylene oxide sterilization.#FDAInnovationChallenge

    The @US_FDA hopes that these challenges will result in new sterilization methods or reduce emissions from ethylene oxide sterilization. #FDAInnovationChallenge [ Read more ]

  • As part of the @US_FDA’s ongoing effort to address the safety and use of ethylene oxide when used to sterilize medical devices, the agency has announced two innovation challenges to encourage new approaches to medical device sterilization. https://go.usa.gov/xyPJR pic.twitter.com/oDXfFuSp6M

    As part of the @US_FDA’s ongoing effort to address the safety and use of ethylene oxide when used to sterilize medical devices, the agency has announced two innovation challenges to encourage new approaches to medical device sterilization. https://go.usa.gov/xyPJR  pic.twitter.com/oDXfFuSp6M [ Read more ]
What's New: Drugs RSS Feed

  • Kingston Pharma, LLC RECALLS " DG™/Health NATURALS Baby Cough Syrup + Mucus” Because of Possible Health Risk

    Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce [ Read more ]

  • Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

    ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity. [ Read more ]

  • Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up

    Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets. [ Read more ]

  • Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

    Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confi [ Read more ]

  • Meetings, Conferences, & Workshops (Drugs)

    Drugs-Related Meetings [ Read more ]

  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API)

    Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Met [ Read more ]

  • What's New Related to Drugs

    Want to know what's new? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. [ Read more ]

  • Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

    Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity [ Read more ]

  • Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance

    Houston, Texas, Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products t [ Read more ]

  • Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 02/19/2020 - 02/19/2020

    The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by CDER and CBER [ Read more ]

  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)

    Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection [ Read more ]

  • Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply

    Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). [ Read more ]

  • Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

    Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter [ Read more ]

  • Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination

    Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. [ Read more ]

  • USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil

    USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed

  • Application Submissions Guidances

    This page lists Application Submissions Guidance documents. [ Read more ]

  • Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

    Guidance clarifying the requirements of FDA regulations on human subject protection (21 CFR part 50) and IRBs (21 CFR part 56) and the Department of Health and Human Services' Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”). [ Read more ]

  • Cleared 510(k) Submissions with Supporting Documents - 2019

    List of Cleared 510(k) Submissions with Supporting Documents for 2019 [ Read more ]

  • ALPROLIX

    Product approval information is indicated for adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes, (2) Perioperative management, (3) Routine prophylaxis to reduce the frequency of bleeding episodes. [ Read more ]

  • Postmarketing Safety Reporting for Combination Products

    Final guidance for industry and FDA staff: Postmarketing Safety Reporting for Combination Products [ Read more ]

  • Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

    This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee. [ Read more ]

  • MedWatch: The FDA Safety Information and Adverse Event Reporting Program

    MedWatch home page [ Read more ]

  • Consumer Updates

    Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more. [ Read more ]

  • Bayer Statement on Voluntary Recall of Two Lots of Kogenate® FS Antihemophilic Factor (Recombinant) in the United States

    Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia [ Read more ]

  • What’s New for Biologics

    Latest news from the Center for Biologics Evaluation and Research [ Read more ]

  • Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop - 09/16/2019 - 09/17/2019

    The purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications. [ Read more ]

  • Emergency Use Authorization

    The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies [ Read more ]

  • Biologics PREA Reviews and Labeling Changes

    PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. [ Read more ]

  • Recently Issued Guidance Documents

    This page lists Recently Issued CBER and Cross-Center Guidance Documents. [ Read more ]

  • Antimicrobial Resistance Information from FDA

    Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. [ Read more ]

News & Events

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  • Statins May Slow Progression Of Multiple Sclerosis, New Study Finds A UCSF-led study exa... Read more>>
  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
  • in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>
  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratori... Read more>>
  • FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>

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