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 Roundup: January 25, 2022
Tue, 25 Jan 2022 16:12:01 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
Mon, 24 Jan 2022 16:37:58 EST

  The FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.

FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19
Fri, 21 Jan 2022 18:16:54 EST

  The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.

FDA Roundup: January 21, 2022
Fri, 21 Jan 2022 14:36:00 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: January 18, 2022
Tue, 18 Jan 2022 16:03:07 EST

  he U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women
Tue, 18 Jan 2022 10:02:20 EST

  The FDA’s Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan to further the FDA’s mission by protecting and promoting the health of all women.

FDA Roundup: January 14, 2022
Fri, 14 Jan 2022 14:09:49 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products
Thu, 13 Jan 2022 11:29:36 EST

  Interagency Working Group on Asbestos in Consumer Products (IWGACP) White Paper offers opinions on testing methods of talc-containing cosmetics products to assess the presence of asbestos

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species
Thu, 13 Jan 2022 10:22:16 EST

  FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

FDA Roundup: January 11, 2022
Tue, 11 Jan 2022 17:02:46 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: January 7, 2022
Fri, 07 Jan 2022 16:09:48 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months
Fri, 07 Jan 2022 08:59:06 EST

  The FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.

FDA Roundup: January 4, 2022
Tue, 04 Jan 2022 18:36:47 EST

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
Mon, 03 Jan 2022 09:31:49 EST

  The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.

Coronavirus (COVID-19) Update: December 28, 2021
Tue, 28 Dec 2021 15:26:49 EST

  Coronavirus (COVID-19) Update: December 28, 2021

Coronavirus (COVID-19) Update: December 23, 2021
Thu, 23 Dec 2021 12:08:07 EST

  Coronavirus (COVID-19) Update: December 23, 2021

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
Thu, 23 Dec 2021 09:19:05 EST

  The FDA issued an emergency use authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in certain adults.

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them
Thu, 23 Dec 2021 09:04:15 EST

  The FDA authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products, which help reduce exposure to and consumption of nicotine for smokers who use them.

FDA In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Dole Packaged Salad
Wed, 22 Dec 2021 19:38:09 EST

  The FDA, along with the CDC and our state and local partners, is investigating a multistate outbreak of Listeria monocytogenes infections potentially linked to Dole packaged salad.

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
Wed, 22 Dec 2021 12:08:03 EST

  Today, the FDA issued an emergency use authorization for the first oral antiviral for treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds).

Food and Drugs Administration--Recalls/Safety Alerts

Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination
Thu, 27 Jan 2022 00:00:00 EST

  Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care to the consumer level because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus. Patients who apply the contaminated product to a wound could develop a skin and soft

Siren Issues a Voluntary Allergy Alert on Undeclared Cashews and Almond Butter in Birthday Cake Bites
Thu, 27 Jan 2022 00:00:00 EST

  Siren of San Francisco, CA is issuing a voluntary recall of Siren Birthday Cake 1.7oz Bites because they may contain undeclared cashews and almond butter. People who have an allergy or severe sensitivity to cashew or almond butter run the risk of serious allergic reaction if they consume these produ

Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Wed, 19 Jan 2022 21:03:00 EST

  Amy’s Kitchen is initiating a voluntary Class I recall of Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze due to the potential of having trace amounts of milk, which is not declared on the product label. The company is recalling this single lot out of an abundance of caution to ensure the safety

BCS International Corp. Issues Alert on Undeclared Sulfites in “Dr. Snack Goji Berry”
Wed, 19 Jan 2022 00:00:00 EST

  BCS International Corp. Long Island City, NY, is recalling its 4.5 ounce, 6 ounce and 9 ounce containers and 5 pound packages of “Dr. Snack Goji Berry” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatenin

Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Wed, 19 Jan 2022 00:00:00 EST

  Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
Tue, 18 Jan 2022 00:00:00 EST

  Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f

Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Fri, 14 Jan 2022 00:00:00 EST

  Lily’s Sweets, is voluntarily recalling 18,855 cases of 7-ounce Peppermint Flavor Baking Chips due to the presence of soy lecithin. People who have a severe allergy or sensitivity to soy should not consume these products. The product was a limited holiday seasonal offering available exclusively a

Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use
Wed, 12 Jan 2022 00:00:00 EST

  Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the devic

Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination
Tue, 11 Jan 2022 00:00:00 EST

  Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing li

Poppies International Expands Voluntary Recall of Chocolate Enrobed and Cream Puff Products Due to Presence of Metal
Mon, 10 Jan 2022 00:00:00 EST

  Poppies International, Inc. of Battleboro, NC is expanding their voluntary recall to include the Taste of Inspirations Crème Puffs 30ct container, UPC 7 25439 99597 9, Lot # L2I5021 Best Before Date 06/08/23 that were made during December 7-10, 2021, due to the possible presence of small metal fragm

Moor Herbs Recalls “Angel Formula” Infant Formula Because of Possible Health Risk
Fri, 07 Jan 2022 00:00:00 EST

  Moor Herbs of Detroit, MI is recalling it's Angel Formula, because FDA testing determined that the product did not meet specific nutrition and labeling requirements for infant formula, even though it is marketed as such. When the product was tested, the iron, sodium, and potassium content were well

Dole Fresh Vegetables, Inc. Announces Voluntary Recall for Certain Salads Processed at its Springfield, OH and Soledad, CA Facilities and Containing Iceberg Lettuce Due to Possible Health Risk from Listeria monocytogenes
Fri, 07 Jan 2022 00:00:00 EST

  Dole Fresh Vegetables, Inc. is voluntarily recalling from the market all Dole-branded and private label packaged salads described below processed at its Springfield, OH and Soledad, CA production facilities containing iceberg lettuce, due to a possible health risk from Listeria monocytogenes. Lister

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Fri, 07 Jan 2022 00:00:00 EST

  Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitroso

World Health Products, LLC. Issues Allergy Recall on Undeclared Milk Allergen in Jetfuel Diuretic
Thu, 06 Jan 2022 00:00:00 EST

  World Health Products, llc. of Monroe, CT is recalling Jetfuel Diuretic UPC 859613000859, because it may contain 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. The GAT Sport Jetfuel

GHGA, LLC. Issues Allergy Alert on Undeclared Fish in Chicken Salad Croissants
Mon, 03 Jan 2022 00:00:00 EST

  GHGA, LLC. is voluntarily recalling 266, 7.8 oz. packages of Chicken Salad Croissants due to undeclared fish. People who are allergic to fish run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled product was shipped to Kroger stores in Alabama, Geor

Haifa Smoked Fish Inc Expands Recall of Turbot Cold Smoked 8 oz Package Lots # 97, 223, 299, 321 Because of Possible Health Risk
Wed, 29 Dec 2021 00:00:00 EST

  HAIFA SMOKED FISH of Jamaica, NY is expanding their recall of Turbot Cold Smoked 8 oz Packages to include 920 LB of Turbot from Lots 97, 223, 299, 321. The products have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections i

Relish Foods, Inc Recalls Frozen Tuna Steaks Because of Possible Health Risk
Tue, 28 Dec 2021 00:00:00 EST

  On December 27, 2021, Relish Foods, Inc of El Segundo, California voluntarily initiated the recall of Frozen Pacific Fusion Brand 10 oz Tuna Steaks. The recall was the result of a consumer complaint whereafter sampling by FDA revealed that the product has potential to contain elevated levels of hist

Dianne's Fine Desserts Issues Allergy Alert on Undeclared Pecan Allergen in Sienna® Chocolate Decadent Brownie
Tue, 28 Dec 2021 00:00:00 EST

  Dianne's Fine Desserts of Newburyport, MA 01950 is recalling 1,480 trays of Sienna® Chocolate Decadent Brownies due to a mis-pack, resulting in an undeclared tree nut (pecan). People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if

Poppies International, Inc. Battleboro, North Carolina Issues Voluntary Recall on Certain Lots of Chocolate Enrobed and Cream Puff Products Due to Possible Presence of Metal
Tue, 28 Dec 2021 00:00:00 EST

  Poppies International, Inc. of Battleboro, NC is issuing a voluntary recall of selected products that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. No injuries or incidents have been reported in connection wit

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination
Mon, 27 Dec 2021 00:00:00 EST

  Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product

What's New: Drugs RSS Feed

Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination
Thu, 27 Jan 2022 16:59:22 EST

  Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care to the consumer level because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus. Patients who apply the contaminated product to a wound could develop a skin and soft

Drug Safety and Risk Management Advisory Committee Roster
Thu, 27 Jan 2022 16:52:43 EST

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

Anesthetic and Analgesic Drug Products Advisory Committee Roster
Thu, 27 Jan 2022 16:47:49 EST

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

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination
Thu, 27 Jan 2022 16:31:26 EST

  Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

Compounding: Inspections, Recalls, and other Actions
Thu, 27 Jan 2022 16:29:07 EST

  Human drug compounding; FDA inspections; compounding recalls

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
Thu, 27 Jan 2022 16:03:16 EST

  To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

What's New Related to Drugs
Thu, 27 Jan 2022 14:37:40 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.

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
Thu, 27 Jan 2022 13:58:57 EST

  Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.

Know Your Treatment Options for COVID-19
Thu, 27 Jan 2022 13:08:02 EST

  Patients today have more treatment options in the battle against coronavirus disease. FDA has approved one drug treatment for COVID-19 and authorized others for emergency use during this public health emergency.

Generic Drug Facilities, Sites and Organization Lists
Thu, 27 Jan 2022 11:56:02 EST

  Generic Drug Facilities, Sites and Organization Lists

User Fee Lists
Thu, 27 Jan 2022 11:51:05 EST

  Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

Novel Drug Approvals for 2022
Thu, 27 Jan 2022 11:03:58 EST

  Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

FDA Voices
Thu, 27 Jan 2022 10:08:31 EST

  Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

FDA updates on hand sanitizers consumers should not use
Thu, 27 Jan 2022 08:37:59 EST

  FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol

Patent Certifications and Suitability Petitions
Thu, 27 Jan 2022 08:34:28 EST

  Information on patents and suitability petitions that impact the availability of generic drugs.

Inactive Ingredients Database Download
Wed, 26 Jan 2022 18:16:01 EST

  Data updated through January 2022

Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
Wed, 26 Jan 2022 17:40:09 EST

  Exposure to medication is a leading cause of poisoning in children. Kids have died or become seriously ill after being exposed to a skin patch containing fentanyl, an opioid pain reliever. The FDA urges you to take precautions and make sure patches are stored, used, and disposed of properly.

Beware of Vaping Products with Unproven Health Claims
Wed, 26 Jan 2022 15:18:27 EST

  FDA issues warning letters to companies marketing vaping products containing herbal extracts, vitamins, or essential oils. These products, also marketed as inhalers, diffusers, and personal aromatherapy devices, are illegally marketed with unproven health claims.

Oncology (Cancer) / Hematologic Malignancies Approval Notifications
Wed, 26 Jan 2022 14:53:32 EST

  Oncology (Cancer) / Hematologic Malignancies Approval Notifications

FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma
Wed, 26 Jan 2022 14:53:02 EST

  On January 25, 2022, the Food and Drug Administration approved tebentafusp-tebn (Kimmtrak, Immunocore Limited), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Whats New Vaccines Blood Biologics RSS Feed

What’s New for Biologics
Thu, 27 Jan 2022 17:35:16 EST

  Latest news from the Center for Biologics Evaluation and Research

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
Thu, 27 Jan 2022 16:03:16 EST

  To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

Know Your Treatment Options for COVID-19
Thu, 27 Jan 2022 13:08:02 EST

  Patients today have more treatment options in the battle against coronavirus disease. FDA has approved one drug treatment for COVID-19 and authorized others for emergency use during this public health emergency.

Questions about Blood
Thu, 27 Jan 2022 11:09:07 EST

  FDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.

FDA Voices
Thu, 27 Jan 2022 10:08:31 EST

  Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

YESCARTA (axicabtagene ciloleucel)
Thu, 27 Jan 2022 07:30:13 EST

  YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Development & Approval Process (CBER)
Wed, 26 Jan 2022 14:56:22 EST

  Key resources and information related to CBER development & approval process.

Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)
Wed, 26 Jan 2022 14:49:36 EST

  List of Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)

Quick Guide to Web Resources
Wed, 26 Jan 2022 14:45:09 EST

  Quick Guide to Web Resources

Industry (Biologics)
Wed, 26 Jan 2022 14:30:02 EST

  CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

Approved Blood Products
Wed, 26 Jan 2022 14:26:29 EST

  Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

Premarket Approval (PMA) for CBER-Regulated Products
Wed, 26 Jan 2022 14:06:51 EST

  Center for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
Wed, 26 Jan 2022 11:18:23 EST

  CDER Scientific Reviews Supporting EUA for Therapeutic Products

FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022
Tue, 25 Jan 2022 23:42:52 EST

  The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

Drugs@FDA Data Files
Tue, 25 Jan 2022 17:25:45 EST

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

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
Tue, 25 Jan 2022 16:47:54 EST

  Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Janssen COVID-19 Vaccine
Tue, 25 Jan 2022 14:22:45 EST

  Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

COVID-19 Vaccines
Tue, 25 Jan 2022 11:22:55 EST

  FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
Tue, 25 Jan 2022 08:48:32 EST

  From Patient Engagement Advisory Committee recommendations, this draft guidance describes engagement of patient advisors in design and conduct of device trials.

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
Tue, 25 Jan 2022 08:47:42 EST

  Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation





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