Recommendations for cleaning in Healthcare facilities in resource-limited settings ~CDC
***Recommends not using foggers, spray bottles or fumigators***
Guidance and Reference Materials
Disinfection guidance for COVID ~WHO
FDA ?generic drugs? -Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ~FDA
Risk Evaluation and Mitigation Strategies (REMS) for high-risk medications ~FDA
REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
Guidance for developing COVID drugs & biological products ~FDA
Hand Sanitizer Registration process ~FDA
** Excellent collection of FDA registration links
Guidance for Microbiology section of application ~FDA
(This doc is quite old. Not sure if there is a more recent version?)
Hand sanitizer ineligible ingredients ~FDA
EPA List L: Disinfectants for Use Against the Ebola Virus ~EPA
This list of registered disinfectants meets the Center for Disease Control’s (CDC) criteria for use against the Ebola virus on hard, non-porous surfaces.
Classification & Recommendation Outline for Disinfection Methods ~CDC
Highly systematic charts of extremely broad range of methods. Includes analyses and recommendations on fogging, endoscopes & more
Requirements for federal facilities under FIFRA ~EPA
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the Federal statute that governs the registration, distribution, sale, and use of pesticides in the United States.
Disinfection Guidelines for COVID-19 ~Chinese CDCP
Guidelines from Chinese Center for Disease Control and Prevention
Regulations: Good Clinical Practice and Clinical Trials ~FDA
regulations, preambles, human subject protection, good clinical practice, research, investigation, trial, investigator, IRB, institutional review board
Process Safety Management ~OSHA
Process Safety Management (PSM)
Calcs to keep CD level under Process Safety Management limits ~OSHA
HHC's as it applies to pulp and paper industry processes that contain chlorine dioxide. | Occupational Safety and Health Administration
Complete Guide to Hand Sanitizers ~WOW EZ Finishes
As companies re-open post COVID-19 hand hygiene is key. Hand sanitizer is now a necessity for all businesses but what type & where can I find it. This blog covers all angles.
Frequently Asked Questions on Soap ~FDA
Resources for small-scale soap makers
Differences between Soaps, Cosmetics and Drugs ~FDA
An overview of the legal differences between cosmetics and drugs, and whether a cosmetic can be both or just a soap.
FDA Briefs – COVID-19 recent developments Drug and Device Digest
Posts about FDA Briefs written by Drug & Device Advisory Group
Coronavirus Treatment Acceleration Program to help Product Developers during COVID ~CTAP, FDA
CTAP will use every available method to move new treatments to patients as quickly as possible
NIH to launch public-private partnership to speed COVID-19 vaccine ~CTAP, FDA
Health agencies, leading pharmaceutical companies to join forces to accelerate pandemic response.
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for OTC Human Use
2013? 2018? Preliminary Regulatory *Impact Analysis* of *Proposed Amendment* of the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human Use
New Drugs Approval requirements ~US Code laws
21 U.S. Code § 355
Central reference page on Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps ~FDA
FDA letters on topical antiseptic products.
Up-to-date COVID-19 practices
Cleaning & disinfection | PHA Infection Control
{Includes chlorine dioxide}
Emergency Use Authorizations ~FDA
This page lists current Emergency Use Authorizations that make available medical devices to diagnose and respond to public health emergencies.
Search for FDA Guidance Documents ~FDA
Search for official FDA guidance documents and other regulatory guidance for all topics
FDA assistance in expediting COVID treatments ~FDA
FDA has stood up a new program to expedite the development of potentially safe and effective life-saving treatments for COVID-19.
Simple explanation of disinfectants & safety plan steps ~Honk Kong