MedWatch Safety Alert RSS Feed

FDA MedWatch Safety Alerts

Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination

Probability of a potentially sight threatening eye infection or impairment.

[ Read more ]

Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.

[ Read more ]

AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error

Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.

[ Read more ]

Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use

Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.

[ Read more ]

Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

UPDATED 01/30/2018. Primus voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level.

[ Read more ]

"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

[ Read more ]

Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.[ Read more ]

Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

UPDATED 01/23/2018. Recall expanded to include a second lot (NC109123). Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.

[ Read more ]

Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved

Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018

[ Read more ]

Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling

Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018

[ Read more ]

Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter

Use of a non-sterile injectable product could result in fatal infections.

[ Read more ]

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure

Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.

[ Read more ]

Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.

[ Read more ]

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.

[ Read more ]

Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced

General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.

[ Read more ]

Food and Drug Administration--Press Releases

Press releases from FDA

Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure

One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on a myriad scientific evidence developed over many years to help inform our regulatory thinking. Although the Federal Communications Commission (FCC) sets the standard for radiofrequency energy exposure limits from cell phones, the FCC relies on the FDA and other health agencies for scientific expertise and input regarding those standards.

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

[ Read more ]

FDA, USDA announce formal agreement to bolster coordination and collaboration

FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.

[ Read more ]

FDA approves new treatment for certain digestive tract cancers

FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study

FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study

[ Read more ]

FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims

FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls

FDA discusses new policy steps for strengthening public warning and notification of recalls

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.

[ Read more ]

FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids

FDA updates on some ongoing shortages related to IV fluids

[ Read more ]

FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel

The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.

[ Read more ]

FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs

FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals

[ Read more ]

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

[ Read more ]

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

[ Read more ]

Food and Drug Administration--Recalls/Safety Alerts

Recall Information from FDA

JFC International Inc. Issues Allergy Alert on Undeclared Crustacean Shellfish (Shrimp, Crab) in Daisho Kimchi Hot Pot Soup Base

JFC International Inc. of Los Angeles, CA is voluntarily recalling a Kimchi Hot Pot Soup Base because it was found to contain undeclared Crustacean Shellfish (Shrimp, Crab). Individuals who have allergies to crustacean shellfish (shrimp, crab) runs the risk of a serious life-threatening allergic reaction if they consume the product. One incident has been reported to date in connection with this issue.

[ Read more ]

Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

[ Read more ]

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

[ Read more ]

Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products

While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.

[ Read more ]

Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement

Out of an abundance of caution, Bulletproof 360, Inc. is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

[ Read more ]

National Frozen Foods Corporation Recalls Frozen Green Beans and Frozen Mixed Vegetables Because of Possible Health Risk

National Frozen Foods Corporation (NFFC) is voluntarily recalling a limited quantity of Not-Ready-To Eat Individually Quick Frozen (IQF) green beans and IQF mixed vegetables because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

[ Read more ]

Products Pacheco Inc Issues Allergy Alert For Undeclared Wheat, Soy, Egg, Milk and Undeclared Artificial Coloring in its Bakery Products

PRODUCTS PACHECO INC. in Bayamón, Puerto Rico, is recalling the following products of PACHECO brand because they may contain undeclared allergens: Wheat, Soy, Egg, Milk and artificial coloring not listed: Red#40, Yellow#5, Yellow#6. People who have allergies to these foods run the risk of serious or life-threatening allergic reaction if they consume these products

[ Read more ]

Sun Noodle - New Jersey - Issues Allergy Alert on Undeclared Fish in Tonkotsu Ramen

Sun Noodle of Carlstadt, NJ is voluntarily recalling one lot of their retail Tonkotsu Ramen because it is mis-labeled. While it is labeled Tonkotsu, the actual flavor packet inside is Assari Shoyu, which contains an additional undeclared allergen of fish (sardines).

[ Read more ]

Productos Pacheco Inc Emite La Alerta De Alergenos No Declarados: Trigo, Soya, Huevo, Leche Y Colorantes No Declarados En Sus Productos De Panaderia

PRODUCTOS PACHECO INC. en Bayamón, Puerto Rico, está recogiendo los siguientes productos marca PACHECO porque pueden contener alérgenos no declarados: Trigo, Soya, Huevo, Leche y colorantes artificiales no listados en ingredientes Rojo#40, Amarillo#5, Amarillo#6. Las personas que tienen alergias a estos alimentos y colores artificiales corren el riesgo de una reacción alérgica grave o que pone en peligro la vida si consumen estos productos.

[ Read more ]

Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

Tigard, OR, Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

[ Read more ]

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

[ Read more ]

Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk

Break Ventures/California Basics is recalling its Dietary Supplement "Zero for Him 150ct" Lot#1710-638(the "Product") because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

[ Read more ]

Arthri-D, LLC Recalls Arthri-D Lot#1701-092 Because of Possible Health Risk

Arthri-D, LLC is recalling its Dietary Supplement "Arthri-D 120ct" Lot#1701-092 (the "Product") because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

[ Read more ]

JustFoodForDogs Voluntarily Recalls Three Daily Diets because of Possible Listeria monocytogenes Health Risk from Green Beans

JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the company is alerting the public.

[ Read more ]

Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup

Ottogi America, Inc. of Gardena, CA is recalling 6.40 ounce “Rice cake soup” food, because it may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

[ Read more ]

Twitter Search / FDADeviceInfo

Twitter feed for: FDADeviceInfo. Generated by TwitRSS.me

CDRH's Bakul Patel talks #DigitalHealth and #FDAPrecert today at 10:15am with entrepreneurs, innovators and startups http://bit.ly/HHSStartupDay  #HHSstartupday

CDRH's Bakul Patel talks #DigitalHealth and #FDAPrecert today at 10:15am with entrepreneurs, innovators and startups http://bit.ly/HHSStartupDay  #HHSstartupday

[ Read more ]

Despite reports that this year’s flu vaccine shows diminished efficacy against the predominant H3N2 strain, a vaccine is still your best bet. As in past years, we’re seeing an increase in H1N1 relative to H3N2 as the season progresses; and vaccine efficacy against H1N1 is goodpic.twitter.com/SG8sq2tE77

Despite reports that this year’s flu vaccine shows diminished efficacy against the predominant H3N2 strain, a vaccine is still your best bet. As in past years, we’re seeing an increase in H1N1 relative to H3N2 as the season progresses; and vaccine efficacy against H1N1 is good pic.twitter.com/SG8sq2tE77

[ Read more ]

#FDA has seen reports of spot shortages of flu related antiviral drugs, where an individual pharmacy may be out of drug. But there’s ample overall supply and no drug shortage. If you have flu-like symptoms please consult your doctor for treatment options http://go.usa.gov/xn7uW pic.twitter.com/4Pl109GN2O

#FDA has seen reports of spot shortages of flu related antiviral drugs, where an individual pharmacy may be out of drug. But there’s ample overall supply and no drug shortage. If you have flu-like symptoms please consult your doctor for treatment options http://go.usa.gov/xn7uW  pic.twitter.com/4Pl109GN2O

[ Read more ]

While early indications are that flu vaccines may not be as effective against the H3N2 strain this year as previous flu seasons, the best protection still is to get vaccinated. It also protects against other strains circulating this year besides H3N2: http://go.usa.gov/xnAgz pic.twitter.com/mgakpQKoia

While early indications are that flu vaccines may not be as effective against the H3N2 strain this year as previous flu seasons, the best protection still is to get vaccinated. It also protects against other strains circulating this year besides H3N2: http://go.usa.gov/xnAgz  pic.twitter.com/mgakpQKoia

[ Read more ]

FDA Identified Class I Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error https://go.usa.gov/xn7FG  #MedicalDevice

FDA Identified Class I Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error https://go.usa.gov/xn7FG  #MedicalDevice

[ Read more ]

Continue the conversation about #DigitalHealth with FDA. Send your comments to the docket https://go.usa.gov/xn7gb  #MedicalDevice #FDAPrecert

Continue the conversation about #DigitalHealth with FDA. Send your comments to the docket https://go.usa.gov/xn7gb  #MedicalDevice #FDAPrecert

[ Read more ]

FDA discusses data aggregation tools for #DigitalHealth with DH technology and medical device companies https://go.usa.gov/xn7gY  #MedicalDevice #FDAPrecert

FDA discusses data aggregation tools for #DigitalHealth with DH technology and medical device companies https://go.usa.gov/xn7gY  #MedicalDevice #FDAPrecert

[ Read more ]

Bakul Patel talks modernizing regulatory structures while preserving standards of safety and effectiveness for #DigitalHealth tech https://go.usa.gov/xn7gx  #MedicalDevice #FDAPrecert

Bakul Patel talks modernizing regulatory structures while preserving standards of safety and effectiveness for #DigitalHealth tech https://go.usa.gov/xn7gx  #MedicalDevice #FDAPrecert

[ Read more ]

Thank you for joining us on Day 1 of our #DigitalHealth workshop. FDA will discuss drivers of excellence and key performance indicators on Day 2 https://go.usa.gov/xn7rM  #MedicalDevice #FDAPrecert

Thank you for joining us on Day 1 of our #DigitalHealth workshop. FDA will discuss drivers of excellence and key performance indicators on Day 2 https://go.usa.gov/xn7rM  #MedicalDevice #FDAPrecert

[ Read more ]

New questions answered about the #Digitalhealth #FDAPrecert pilot program https://go.usa.gov/xn7cG  #MedicalDevice

New questions answered about the #Digitalhealth #FDAPrecert pilot program https://go.usa.gov/xn7cG  #MedicalDevice

[ Read more ]

Great insights shared today from #FDAPrecert participants at FDA’s #DigitalHealth public workshop. Docket is open for your input on #FDAPrecert https://go.usa.gov/xn7qs  #MedicalDevice

Great insights shared today from #FDAPrecert participants at FDA’s #DigitalHealth public workshop. Docket is open for your input on #FDAPrecert https://go.usa.gov/xn7qs  #MedicalDevice

[ Read more ]

Jeff Shuren talks #DigitalHealth. FDA develops #FDAPrecert collaboratively to ensure timely access to high-quality, safe and effective DH products

Jeff Shuren talks #DigitalHealth. FDA develops #FDAPrecert collaboratively to ensure timely access to high-quality, safe and effective DH products

[ Read more ]

CDRH 2018-2020 Strategic Priorities Unveiled: Employee Engagement, Opportunity, and Success; Simplicity; and Collaborative Communities. https://go.usa.gov/xnvUB pic.twitter.com/KVHvLNSeIb

CDRH 2018-2020 Strategic Priorities Unveiled: Employee Engagement, Opportunity, and Success; Simplicity; and Collaborative Communities. https://go.usa.gov/xnvUB  pic.twitter.com/KVHvLNSeIb

[ Read more ]

#FDA issues safety communication for Zoll LifeVest 4000! Device may display “Message Code 102,” and potentially fail to deliver treatment! #MedicalDevice https://go.usa.gov/xnv5V 

#FDA issues safety communication for Zoll LifeVest 4000! Device may display “Message Code 102,” and potentially fail to deliver treatment! #MedicalDevice https://go.usa.gov/xnv5V 

[ Read more ]

Consumer Information on: ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® Professional Defibrillators - P160022 https://go.usa.gov/xnpvt 

Consumer Information on: ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® Professional Defibrillators - P160022 https://go.usa.gov/xnpvt 

[ Read more ]

What's New: Drugs RSS Feed

What's New at CDER

FDA Adverse Event Reporting System (FAERS) Public Dashboard

Four FAERS summary statistics reports updated with data through December 31, 2013.

[ Read more ]

FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease

The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

[ Read more ]

Inactive Ingredients Database Download

Data updated through July 2017

[ Read more ]

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

[ Read more ]

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

FDA Adverse Event Reporting System (FAERS) - Quarterly Data Extract (QDE): The Quarterly Data Extract files, contain raw data extracted from the FAERS database for the indicated time ranges (not cumulative), in ASCII or SGML formats.

[ Read more ]

Pulmonary-Allergy Drugs Advisory Committee Roster

This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.

[ Read more ]

Medication Guides

Medication Guides from A to Z. Guides provide information on proper drug use, safety, and storage. Visit our page for more info.

[ Read more ]

Office of Translational Sciences

The Office of Translational Sciences (OTS) oversees CDER research involving human subjects, the CDER Oak Ridge Institute for Science and Education (ORISE) Program, and CDER regulatory science research.

[ Read more ]

Office of Strategic Programs

The Office of Strategic Programs (OSP) leads Center-wide strategic and operational planning and analysis.

[ Read more ]

Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation

Clinical / Antimicrobial

[ Read more ]

Drugs@FDA Download File (new structure)

Drugs@FDA Data files updated weekly

[ Read more ]

Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

[ Read more ]

FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse

[06-07-2016] The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death.

[ Read more ]

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

FDA is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years and must not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against using codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

[ Read more ]

Newly Added Guidance Documents

Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

[ Read more ]

What's New: Vaccines, Blood & Biologics RSS Feed

Documents recently posted on the CBER Web Site

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

Contains list of Establishments Granted Approval for a Variance to 21CFR640.3 (d) and 21CFR640.3 (f) that contains names of Facility, addresses, Licensed, Registered-Only, 640.3(d) Approvals, 640.3(f) Approvals and Approval Date.

[ Read more ]

Biologics Guidances

This page displays links to Biologics Guidance documents.

[ Read more ]

Abbott Prism Chagas

The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens.

[ Read more ]

ORTHO T. cruzi ELISA Test System

Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating

[ Read more ]

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2018

Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2018.

[ Read more ]