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Barcode Five Rights System

Use Barcode to prevent medication errors

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

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 ®.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

FDA Press Releases RSS Feed

Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
Thu, 05 Dec 2019 18:22:39 EST

The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.

FDA approves first generics of Gilenya
Thu, 05 Dec 2019 15:14:20 EST

The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria
Thu, 05 Dec 2019 11:52:28 EST

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
Thu, 05 Dec 2019 10:19:49 EST

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

FDA approves novel treatment to target abnormality in sickle cell disease
Wed, 04 Dec 2019 16:56:15 EST

FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Mon, 02 Dec 2019 12:32:51 EST

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
Wed, 27 Nov 2019 12:30:04 EST

FDA issues guidance to help make development of biosimilar and interchangeable insulin products more efficient.

California-based food manufacturer agrees to stop production after repeated food safety violations
Tue, 26 Nov 2019 16:18:17 EST

California-based food manufacturer agrees to stop production after repeated food safety violations

Statement on new steps to advance innovation in medical device sterilization with ethylene oxide
Tue, 26 Nov 2019 13:31:50 EST

FDA is announcing the next steps in our ongoing efforts in medical device sterilization with ethylene oxide. This includes the selection results of our new Innovation Challenges, a recap and action items from our recent public advisory committee meeting, and the announcement of a new pilot program.

Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk
Tue, 26 Nov 2019 11:38:58 EST

FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development

FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection
Mon, 25 Nov 2019 17:44:07 EST

FDA has approved a new system, the Tubes Under Local Anesthesia (Tula) System, for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections.

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Mon, 25 Nov 2019 17:33:14 EST

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

FDA approves new treatment for adults with partial-onset seizures
Thu, 21 Nov 2019 16:52:18 EST

Today, the FDA approved a new treatment for adults with partial-onset seizures

FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia
Thu, 21 Nov 2019 10:44:11 EST

As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma

FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
Wed, 20 Nov 2019 15:38:54 EST

Today the FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.

FDA approves first treatment for inherited rare disease
Wed, 20 Nov 2019 12:25:57 EST

: FDA grants approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood)

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
Fri, 15 Nov 2019 18:29:10 EST

FDA has taken another step to further foster biologics competition with the approval of 25th biosimilar, Abrilada (adalimumab - afzb), a biosimilar to Humira.

FDA approves first contact lens indicated to slow the progression of nearsightedness in children
Fri, 15 Nov 2019 17:07:40 EST

FDA approved the first contact lens to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems. MiSight is a daily, disposable contact lens approved for children 8-12 at the start of treatment.

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
Fri, 15 Nov 2019 15:32:46 EST

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
Fri, 15 Nov 2019 14:03:09 EST

The FDA today cleared the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.

Food and Drugs Administration--Recalls/Safety Alerts

The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns
Thu, 05 Dec 2019 18:20:40 EST

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers
Thu, 05 Dec 2019 11:53:55 EST

Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens.

Dole Fresh Vegetables Announces Precautionary Limited Recall of Colorful Coleslaw
Tue, 03 Dec 2019 21:05:09 EST

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw.

Lin’s Waha Int’l Corp Issues Alert on Undeclared Sulfites and Cyclamates in “Suantianyangmei Waxberry and Bingtangyangmei Waxberry”
Tue, 03 Dec 2019 14:05:18 EST

Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates.

Fuji Food Products, Inc. Voluntarily Recalls Ready-to-Eat Sushi, Salads and Spring Rolls Manufactured on the East Coast Due to Potential Listeria monocytogenes Contamination
Mon, 02 Dec 2019 10:33:47 EST

Fuji Food Products, Inc. (Fuji) announced today the voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest.

UNFI Voluntarily Recalls Wild Harvest® Organic All-Purpose Flour, Unbleached
Wed, 27 Nov 2019 18:38:23 EST

UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules Due to an Undeclared PDE-5 Inhibitor Found in the Product
Wed, 27 Nov 2019 18:12:26 EST

Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor.

Hodgson Mill Issues Voluntary Recall of Unbleached All-Purpose White Wheat Flour Due to Potential Presence of Pathogenic E.coli
Wed, 27 Nov 2019 12:10:18 EST

Hodgson Mill of Effingham, IL, announced today a voluntary national recall of specific lots of its Unbleached All-Purpose White Wheat Flour (5 lb.)

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing
Tue, 26 Nov 2019 13:32:36 EST

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.

Northern Fisheries LTD. Voluntary Expanded Tuna Recall Press Release
Mon, 25 Nov 2019 13:18:48 EST

Northern Fisheries LTD of Little Compton, RI, has expanded their voluntary recall of frozen, wild-caught yellowfin Tuna Medallions (product of Vietnam) to include product sold directly to consumers. This recall is due to potentially elevated levels of histamine.

Allergy Alert Issued due to Undeclared Egg in Whole Foods Market Brand Raspberry Cheesecake Italian Gelato
Fri, 22 Nov 2019 19:34:28 EST

Whole Foods Market is voluntarily recalling one lot code of Whole Foods Market Raspberry Cheesecake Italian Gelato because these product units contain egg that is not listed on the product label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening alle

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Fri, 22 Nov 2019 17:08:31 EST

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg


“Euroline Foods LLC” Issues Alert on Undeclared Sulfites In “Dry Fruit Mix “Quince Compote” (Tainy Vostoka)”
Thu, 21 Nov 2019 18:34:55 EST

“Euroline Foods LLC” of Staten Island, NY is recalling its 17.65oz (500 gram) packages of “DRY FRUIT MIX “QUINCE COMPOTE” ” because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this

Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potential Presence of Foreign Material
Wed, 20 Nov 2019 14:03:18 EST

Mondelēz Global LLC announced today a voluntary recall of a limited quantity of Cheese Nips (11 oz. Box) product in the United States due to the potential presence of small food-grade yellow plastic pieces from a dough scraper that was incorporated into the production process of a small amount of pr

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Wed, 20 Nov 2019 12:28:38 EST

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material
Mon, 18 Nov 2019 16:21:24 EST

Select varieties of Breakstone’s Cottage Cheese are voluntarily being recalled due to the potential presence of pieces of red plastic and metal that may have been introduced during production.

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Mon, 18 Nov 2019 16:20:49 EST

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk
Mon, 18 Nov 2019 16:19:30 EST

Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella.

CHS Inc. Recalls Payback® Feeds Because of Excess Magnesium Health Risk
Wed, 13 Nov 2019 23:29:22 EST

CHS Inc., based in Inver Grove Heights, Minnesota, is voluntarily recalling 67 tons of Payback® Feeds listed below due to potentially high levels of magnesium.

Natural Grocers Issues Recall on Organic Soybeans Due to Mold
Wed, 13 Nov 2019 22:13:37 EST

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 2-pound Organic Soybeans because they have the potential to contain mold. Consumers who may have purchased this product are advised to discontinue use and either throw it

What's New: Drugs RSS Feed

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
Thu, 05 Dec 2019 15:32:42 EST

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

FDA approves first generics of Gilenya
Thu, 05 Dec 2019 15:14:20 EST

The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making - 12/06/2019 - 12/06/2019
Thu, 05 Dec 2019 14:57:26 EST

The U.S Food and Drug Administration (FDA) is hosting a public workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders.

What's New Related to Drugs
Thu, 05 Dec 2019 14:45:52 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.

Don't Double Up on Acetaminophen
Thu, 05 Dec 2019 14:40:08 EST

More than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

Generic Drugs Collaboration Opportunities
Thu, 05 Dec 2019 14:05:09 EST

The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.

MannKind Corporation - 578282 - 10/05/2018
Thu, 05 Dec 2019 14:02:49 EST

False & Misleading Claims/Misbranded


FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations
Thu, 05 Dec 2019 13:50:41 EST

Oncology News Burst

Antimicrobial Resistance Information from FDA
Thu, 05 Dec 2019 13:36:19 EST

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.

Endocrinologic and Metabolic Drugs Advisory Committee Roster
Thu, 05 Dec 2019 13:22:30 EST

Advisory Committees (Drugs)

Drug Safety Oversight Board
Thu, 05 Dec 2019 11:40:25 EST

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Reso

Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) Roster
Thu, 05 Dec 2019 11:27:15 EST

This page contains the BRUDAC roster, which lists the current members and the current number of vacancies for the committee.

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
Thu, 05 Dec 2019 10:19:49 EST

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

FDA approves novel treatment to target abnormality in sickle cell disease
Wed, 04 Dec 2019 16:56:15 EST

FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
Wed, 04 Dec 2019 16:17:24 EST

FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines

CDER Small Business & Industry Assistance (SBIA)
Wed, 04 Dec 2019 15:26:27 EST

This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.

2019 Meeting Materials, Oncologic Drugs Advisory Committee
Wed, 04 Dec 2019 14:58:17 EST

This page contains the meeting materials for the Oncologic Drugs Advisory Committee meetings for 2019, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, etc.

UPDATED PUBLIC PARTICIPATION INFORMATION: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 12/17/2019 - 12/17/2019
Wed, 04 Dec 2019 14:57:32 EST

UPDATED PUBLIC PARTICIPATION INFORMATION: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019 - 11/22/2019 - 11/22/2019
Wed, 04 Dec 2019 14:26:59 EST

The Study Data TGC provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The TCG supplements the guidance for industry

Research Tools and Resources
Wed, 04 Dec 2019 13:46:02 EST

Scientific tools, databases, and information for drug developers

Whats New Vaccines Blood Biologics RSS Feed

No es demasiado tarde para vacunarse contra la gripe
Thu, 05 Dec 2019 16:22:12 EST

¿Piensa que es demasiado tarde para vacunarse contra la gripe? iEl otoño ya está aquí y es tiempo de vacunarse contra la gripe estacional anual. Lo mejor es vacunarse al comienzo de la temporada de gripe.



Antimicrobial Resistance Information from FDA
Thu, 05 Dec 2019 13:36:19 EST

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.

Licensed Biological Products with Supporting Documents
Thu, 05 Dec 2019 12:01:47 EST

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

What’s New for Biologics
Thu, 05 Dec 2019 11:25:26 EST

Latest news from the Center for Biologics Evaluation and Research

Panoscreen EXTEND
Thu, 05 Dec 2019 10:58:19 EST

Detection of expected and unexpected red cell blood group antibodies

CBER Reports
Thu, 05 Dec 2019 10:40:35 EST

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

Jobs at the Center for Biologics Evaluation and Research (CBER)
Thu, 05 Dec 2019 07:36:24 EST

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)
Thu, 05 Dec 2019 07:31:23 EST

The Center for Biologics Evaluation and Research is recruiting to fill a Physician position to serve in the Division of Epidemiology in the Office of Biostatistics and Epidemiology.

Instructions for Completing Form FDA 3500
Wed, 04 Dec 2019 11:24:20 EST

Instructions for Completing Form FDA 3500

BK190389 - ALBAcheck BGS Monoclonal Control
Wed, 04 Dec 2019 09:44:17 EST

ALBAcheck® BGS Monoclonal Control is intended for use as a negative control in conjunction with ALBAclone® Blood Grouping reagents (where referenced in the reagent IFU).

Cleared 510(k) Submissions with Supporting Documents - 2019
Wed, 04 Dec 2019 09:12:11 EST

List of Cleared 510(k) Submissions with Supporting Documents for 2019

BIMO/Team Biologics/Internet Surveillance/Other
Tue, 03 Dec 2019 16:21:14 EST

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

Section 8100: Communication
Tue, 03 Dec 2019 15:21:46 EST

This is the CBER SOPP Section 8100: Communication main page.

Recently Issued Guidance Documents
Tue, 03 Dec 2019 10:56:57 EST

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

Clinical Guidances
Tue, 03 Dec 2019 10:49:46 EST

This page lists Clinical Guidance documents.

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Tue, 03 Dec 2019 07:52:11 EST

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Tue, 03 Dec 2019 06:49:00 EST

Clinical / Medical; Biostatistics

Smoke testing 12-02 Release
Mon, 02 Dec 2019 20:54:34 EST

Smoke testing 12-02 Release

Workshops, Meetings & Conferences (Biologics)
Mon, 02 Dec 2019 17:02:18 EST

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

Facilitating End-to-End Development of Individualized Therapeutics - 03/03/2020 - 03/03/2020
Mon, 02 Dec 2019 16:58:35 EST

The purpose of the public workshop is to foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness.


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