The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]
Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers. We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well. Most of us think […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
FDA Commissioner Stephen M. Hann’s piece on the FDA website (here) provided, I believe, a very realistic view of what one might call a runaway CBD industry (if you read between the lines). “The Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very […]
February 14, 2020 could be called a red letter day in the world of Rx-to-OTC switch. After a long period of drought, FDA announced that they have approved the Rx-to-OTC switch of three prescription drugs. Please see the announcement here. The three drugs are: Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary […]
Tomorrow, the FDA will issue a final rule (see prepublication document here) very similar to its proposed rule published in the Federal Register on September 12, 2018. The notice states “[I]n this final rule, FDA repeals the irradiation regulation, which provided that any drug sterilized by irradiation was a new drug. OTC drugs marketed pursuant to […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling. The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products. As a reminder, the FDA has not regulated child-resistant packaging since 1973, […]
Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]