FDA and COVID-19

FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.

2022-08-26T09:34:00-06:00March 24, 2020|

Gluten in Foods, Drugs and FDA Surveillance

Near the end of 2017 FDA published test results from a gluten free food product surveillance project. By way of background, recall that in 2013 FDA published a final rule on gluten free labeling of foods, including dietary supplements. The rule, codified in 21 CFR [...]

2022-11-29T16:32:55-07:00February 7, 2018|

New Proposal on Antibacterial Soaps

On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]

2022-11-29T16:33:20-07:00December 19, 2013|

Labels as Tables of Contents

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]

2022-11-29T16:33:20-07:00November 12, 2011|

FDA on Sunscreens

In January we told you about some of FDA’s plans for 2011. The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review.  Back in June FDA completed one agenda item, review of proposed [...]

2022-11-29T16:33:20-07:00July 28, 2011|

Johnson & Johnson Consent Decree: A lesson in Drug cGMPs

The folks at Pharmalot have written an article about the Johnson & Johnson consent decree. The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. The consent decree details the systems that need [...]

2022-11-29T16:33:33-07:00March 15, 2011|

FDA’s Agenda for 2011

The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]

2022-11-29T16:33:33-07:00February 23, 2011|
Go to Top