Barcode Five Rights System



Use Barcode to prevent medication errors



ADERS ® is a barcode point of care, (BPOC), solution

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Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see.... Download Adobe PDF Data Sheet

View a PowerPoint Presentation of ADERS ®.





Current Patient Safety and Drug Safety Updates from the FDA


FDA Press Releases RSS Feed

FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
Mon, 02 Nov 2026 08:56:06 EST

  The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.

FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis
Fri, 30 Oct 2026 16:32:08 EDT

  The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).

FDA Launches New Program to Advance Neuroscience Medical Product Development
Thu, 22 Oct 2026 12:58:19 EDT

  FDA announces the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.

FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
Tue, 20 Oct 2026 15:40:38 EDT

  FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.

FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Tue, 20 Oct 2026 11:57:36 EDT

  Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week.

FDA Issues Final Guidance on Prescription Drug Apps and Software
Tue, 20 Oct 2026 09:03:14 EDT

  The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.

FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
Mon, 19 Oct 2026 12:19:38 EDT

  The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments that can have a lasting impact on their daily life.

FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
Wed, 14 Oct 2026 11:50:52 EDT

  The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.

FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer 
Wed, 14 Oct 2026 11:14:51 EDT

  FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer 

FDA Seeks Public Input to Support Ibogaine Research
Mon, 05 Oct 2026 09:02:06 EDT

  The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.

FDA Approves First Heart Valve Designed to Grow with Children
Thu, 01 Oct 2026 15:02:08 EDT

  The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.

FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
Wed, 30 Sep 2026 09:26:33 EDT

  The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.

FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
Tue, 29 Sep 2026 17:01:07 EDT

  The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.

FDA Approves First Treatment for MCT8 Deficiency
Mon, 28 Sep 2026 17:43:18 EDT

  The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patient

FDA intends to evaluate changes to the PMTA regulatory framework
Mon, 28 Sep 2026 17:00:01 EDT

  FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.

Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
Wed, 23 Sep 2026 15:50:17 EDT

  A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.

FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
Mon, 21 Sep 2026 08:58:34 EDT

  The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.

FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
Thu, 17 Sep 2026 14:26:43 EDT

  The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.

FDA Launches Expedited IND Pilot, Begins Accepting Applications
Tue, 15 Sep 2026 09:53:31 EDT

  The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.

FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
Fri, 04 Sep 2026 16:18:49 EDT

  The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)

Food and Drugs Administration--Recalls/Safety Alerts

Vitality Works Inc. Recalls 365 Whole Foods Market Ashwagandha Capsules Sold Nationwide Due to Potential Salmonella Contamination
Fri, 30 Oct 2026 12:16:00 EDT

  Vitality Works Inc. of Albuquerque, New Mexico, is recalling one lot (lot number 2025-26227) of 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha Capsules 120 count because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes f

SLR Food Distribution Inc. Recalls Wise Wife Brand Ground Cinnamon Due to Elevated Lead Levels
Thu, 29 Oct 2026 17:26:00 EDT

  SLR Food Distribution Inc. of Hicksville, New York, is voluntarily recalling Wise Wife Brand Ground Cinnamon because it has the potential to be contaminated with elevated levels of lead.

Taylor Farms Issues Recall for H-E-B Backyard BBQ Chop Salad Kit Due to the Potential Undeclared Soy and Tree Nuts(Almonds)
Tue, 27 Oct 2026 14:18:00 EDT

  Taylor Farms of Dallas, Texas is recalling H-E-B Backyard BBQ Chop Salad kit due to the potential undeclared soy and tree nuts(almonds).

HAIFA SMOKED FISH Recalls Cold Smoked Sprats Due to Potential Health Risk
Tue, 27 Oct 2026 11:15:00 EDT

  HAIFA SMOKED FISH of QUEENS NY is recalling approximately 560 lbs. of Cold Smoked Sprats, due to potential contamination with Clostridium botulinum, a bacterium which can cause life-threatening illness. Consumers are warned not to use the product even if it does not look or smell spoiled.

Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine
Sat, 24 Oct 2026 14:23:00 EDT

  October 24, 2026, Tonight We Ride, LLC of Lakeville, Minnesota is voluntarily recalling all lots of Ultimate Forza Male Supplement capsules to the consumer level because it has been found to contain undeclared Sildenafil, Tadalafil, and Dapoxetine.

Natural Grocers Recalls Natural Grocers Brand Organic 2 Pound Mung Beans Due to Potential Presence of Foreign Material
Thu, 22 Oct 2026 18:59:00 EDT

  10/22/2026, Vitamin Cottage Natural Food Markets, Inc., Lakewood, Colorado, is recalling Natural Grocers Brand Organic 2-Pound Mung Beans due to the potential presence of glass.

WinCo Foods LLC Issues Allergy Alert on Undeclared Sesame in Hoagie Rolls
Thu, 22 Oct 2026 15:42:00 EDT

  October 22, 2026 - WinCo Foods of Boise, ID is recalling the following WinCo Foods Brand Hoagie Rolls due to undeclared sesame.

Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues
Wed, 21 Oct 2026 16:24:00 EDT

  SWEDESBORO, N.J., (October 21, 2026) - Wedgewood Pharmacy LLC ("Wedgewood") is recalling certain compounded veterinary medications within expiry at the provider/customer level due to inconsistencies in the reliability of certain analytical testing data generated by their laboratory, potentially resu

Lidl US Recalls Gelatelli Coffee & Vanilla Gelato Due to Possible Health Risk
Fri, 16 Oct 2026 00:00:00 EDT

  ARLINGTON, VA – OCTOBER 16, 2026 – Lidl US is recalling one lot of Gelatelli Coffee & Vanilla Gelato with Coffee Sauce & Cookie Pieces 16 FL OZ (1 PT) UPC 4 0564897 22458 Lot: 085261 Best By MAR/26/2028 because it has the potential to be contaminated with Listeria monocytogenes, an organism which ca

Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O26:H11 and O45:H2 Contamination
Thu, 15 Oct 2026 16:04:00 EDT

  WORCESTER, NY, October 15, 2026 - Family Farmstead Dairy of Worcester, NY is recalling specific lot of cheddar cheese because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy ad

Pan Pepin Inc. Issues Allergy Alert of Para Bien Al Grano Due to Undeclared Sesame
Tue, 13 Oct 2026 14:07:00 EDT

  Pan Pepin Inc. of Bayamón, Puerto Rico is recalling certain lots of Para Bien Al Grano because the product contain sesame.

Pan Pepín Inc. Emite Alerta por Alérgenos en el Producto Parabien al Grano Debido a la Presencia de Sésamo No Declarado
Tue, 13 Oct 2026 14:00:00 EDT

  Bayamón, Puerto Rico - Pan Pepín Inc., con sede en Bayamón, Puerto Rico, está retirando voluntariamente del mercado ciertos lotes del producto Para Bien Al Grano debido a que contiene sésamo (ajonjolí), un alérgeno que no fue declarado en su etiqueta.

Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter
Tue, 13 Oct 2026 10:52:00 EDT

  FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terepht

Oliva LLC Issues Allergy Alert on Undeclared Sesame in Baba Ghanouj, Spicy Baba Ghanouj, and Hummus
Fri, 09 Oct 2026 15:08:00 EDT

  Oliva LLC of Bethlehem, CT is recalling approximately 250 units of Riad’s Oliva to Go Baba Ghanouj, Spicy Baba Ghanouj, and Hummus, because it may contain undeclared sesame. People who have an allergy or severe sensitivity to sesame run the risk of serious or life-threatening allergic reaction if th

Krasnyi Oktyabr Inc. Recalls Starfish Seafood Trio Because of Possible Health Risk
Fri, 09 Oct 2026 14:41:00 EDT

  Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling Starfish Seafood Trio – Cold Smoked Salmon, Halibut, and Trout, 8 oz (227 g) packages, because the product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal in

Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
Fri, 09 Oct 2026 00:00:00 EDT

  Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infecti

Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination
Thu, 08 Oct 2026 19:51:00 EDT

  October 8, 2026, Gardeners Basics of Spanish Fork, Utah, is recalling one-pound bags of broccoli sprouting seeds because they 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 i

Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter
Thu, 08 Oct 2026 11:08:00 EDT

  FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose.

Eden Brothers Recalls Calabrese Broccoli Seeds Due to Possible Salmonella Contamination
Wed, 07 Oct 2026 16:19:00 EDT

  Arden, NC – October 7th 2026 – Eden Brothers LLC is recalling Calabrese Broccoli Seeds in Packet, 1 Ounce and 1 Pound sizes (Eden Brothers lots 1022067 and 1022068; supplier lot W4105) because we were informed by our supplier that they may be contaminated with Salmonella.

Pacific Health Sciences Voluntarily Recalls One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement
Tue, 06 Oct 2026 13:09:00 EDT

  Pacific Health Sciences is voluntarily recalling one lot of Babies' Magic Tea brand Baby Sleep Gripe Water dietary supplement.

What's New: Drugs RSS Feed

Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
Mon, 02 Nov 2026 16:11:25 EST

  Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

Generic Drug Facilities, Sites and Organization Lists
Mon, 02 Nov 2026 15:57:44 EST

  Generic Drug Facilities, Sites and Organization Lists

FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer
Mon, 02 Nov 2026 14:19:49 EST

  On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon c

Office of Prescription Drug Promotion (OPDP) Metrics
Mon, 02 Nov 2026 14:18:09 EST

  FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs.

Frequently Requested or Proactively Posted Compliance Records
Mon, 02 Nov 2026 09:30:04 EST

  Frequently requested inspection records of foreign pharmaceutical manufacturing facilities

What's New Related to Drugs
Mon, 02 Nov 2026 09:14:07 EST

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

Newly Added Guidance Documents
Mon, 02 Nov 2026 09:12:59 EST

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

Registered Outsourcing Facilities
Mon, 02 Nov 2026 09:11:18 EST

  Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.

Drugs@FDA Data Files
Mon, 02 Nov 2026 08:59:46 EST

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

Recently Issued Biologics Guidance Documents
Mon, 02 Nov 2026 08:55:26 EST

  This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Withdrawn and Expired Guidances | Drugs
Mon, 02 Nov 2026 08:52:51 EST

  Withdrawn and Expired Guidances | Drugs

FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
Mon, 02 Nov 2026 07:20:29 EST

  FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients

CDER Manual of Policies & Procedures | MAPP
Mon, 02 Nov 2026 06:00:04 EST

  CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.

Digital Health Technologies for Drug Development: Demonstration Projects
Fri, 30 Oct 2026 16:02:30 EDT

  Digital Health Technologies for Drug Development Demonstration Projects

Digital Health Technologies (DHTs) for Drug Development
Fri, 30 Oct 2026 16:02:06 EDT

  Digital Health Technologies (DHTs) for Drug Development

Center for Drug Evaluation and Research Organization Chart
Fri, 30 Oct 2026 15:03:48 EDT

  Organization chart for the FDA's Center for Drug Evaluation and Research, including leadership roles.

Generic Drug User Fee Amendments
Fri, 30 Oct 2026 14:49:46 EDT

  This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.

GDUFA Paid Facilities List
Fri, 30 Oct 2026 14:24:33 EDT

  This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Postmarketing Requirements and Commitments: Searchable Database
Fri, 30 Oct 2026 13:43:44 EDT

  Learn more about FDA's Postmarketing Requirements and Commitments Searchable Database.

Notices of Updates
Fri, 30 Oct 2026 13:33:57 EDT

  Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.

Whats New Vaccines Blood Biologics RSS Feed

Blood Guidances
Mon, 02 Nov 2026 15:55:20 EST

  This page contains a listing of Blood Guidances guidances.

What’s New for Biologics
Mon, 02 Nov 2026 09:18:31 EST

  Latest news from the Center for Biologics Evaluation and Research

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus
Mon, 02 Nov 2026 09:12:17 EST

  This is the final guidance Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen

Drugs@FDA Data Files
Mon, 02 Nov 2026 08:59:46 EST

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

Cellular & Gene Therapy Guidances
Mon, 02 Nov 2026 08:57:07 EST

  This page contains a listing of cellular and gene therapy guidances.

Office of Therapeutic Products (OTP) Events, Meetings, and Workshops
Mon, 02 Nov 2026 08:56:25 EST

  Office of Therapeutic Products Events, Meetings, and Workshops

FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
Mon, 02 Nov 2026 08:56:06 EST

  The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.

Recently Issued Biologics Guidance Documents
Mon, 02 Nov 2026 08:55:26 EST

  This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products
Mon, 02 Nov 2026 08:53:44 EST

  This guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product.

Approved Cellular and Gene Therapy Products
Fri, 30 Oct 2026 19:55:49 EDT

  Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis
Fri, 30 Oct 2026 16:32:08 EDT

  The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).

eSubmitter Application History
Fri, 30 Oct 2026 15:37:13 EDT

  History of all updates to the application software in reverse chronological order by version number

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Fri, 30 Oct 2026 08:51:27 EDT

  International Council on Harmonisation - Safety

Procleix Babesia Assay
Thu, 29 Oct 2026 16:24:12 EDT

  The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

West Nile Virus (WNV)
Thu, 29 Oct 2026 15:10:45 EDT

  Lists contain the West Nile Virus products with supporting documents.

Infectious Disease Tests
Thu, 29 Oct 2026 15:05:24 EDT

  Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Expanded Access | Information for Patients
Thu, 29 Oct 2026 14:11:50 EDT

  Expanded access is a pathway designed to make promising medical products available as early in the drug and device evaluation process as possible to patients without therapeutic options, either because they have exhausted or are intolerant of approved therapies, and cannot enter a clinical trial.

Procleix Ultrio Elite Assay
Thu, 29 Oct 2026 12:26:51 EDT

  •Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

PROCLEIX WNV ASSAY
Thu, 29 Oct 2026 11:35:40 EDT

  Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products
Thu, 29 Oct 2026 10:46:25 EDT

  To facilitate and streamline development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological products, by improving the consistency of drug delivery performance information developed and included in applications.





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