510(k) PREMARKET NOTIFICATION GUIDANCE for Contact Lens Care Products

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.

Resources for small-scale soap makers

An overview of the legal differences between cosmetics and drugs, and whether a cosmetic can be both or just a soap.

Posts about FDA Briefs written by Drug & Device Advisory Group

CTAP will use every available method to move new treatments to patients as quickly as possible

Health agencies, leading pharmaceutical companies to join forces to accelerate pandemic response.

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

21 U.S. Code § 355

FDA letters on topical antiseptic products.

{Includes chlorine dioxide}

This page lists current Emergency Use Authorizations that make available medical devices to diagnose and respond to public health emergencies.

Search for official FDA guidance documents and other regulatory guidance for all topics

Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Food and Drug Administration issued this action establishing that certain active ingredients used in nonprescription (OTC)) consumer antiseptic products intended for use without water/consumer...

Previous Exposure Surrogate Reference Tables March 12 - November 2016

{"Nonfood Uses" lists include: "Air treatments" and "HVAC Systems & Humidifiers" in Residential and Public Access Premises; Air Treatments, Critical & Noncritical Items, Hospitals/Medical Institutions (HumanVeterinary nonfood handling areas); Industrial Processes & Water Systems--AC/Refrigeration Condensate, Commercial/Indust Cooling Water, Evaporative Condensor, HVAC, Air Washer} Direct, indirect & non-food uses. Irrigation systems (food crops), egg washing treatment, fruit & vegetable treatments, Commercial, Institutional & Industrial Premises and Equip, Medical Premises and Equipment (inc Air), human drinking water, preservatives for growing or harvested crops, Industrial Processes and Water Systems, Antifoulant Paints and Coatings, Wood Preservatives, Swimming Pools and Spas, Aquatic Areas

Overview of compliance monitoring under the Federal Insecticide, Fungicide, and Rodenticide Act.

Canadian gov website, I think

In order to promote public education and public safety, equal justice for all, a better informed citizenry, the rule of law, world trade and world peace, this...