18
Feb
Budget friendly health brands

When It Rains, It Pours; Recent Rx-to-OTC Switches

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 […]

Read More
13
Dec
Zapping Image

Final Rule Updates “Zapping” Requirements for OTC Products

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 […]

Read More
14
Aug

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

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, […]

Read More
11
Apr
Patiotic cowboy boots

Consumer Antiseptic Rubs Final Rule – or Is It?

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 […]

Read More
20
Dec

Happy Holidays from Us to You!

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 […]

Read More
16
Sep
Yellow warning sign screwed to a brick wall to warn about a threat. In the middle of the panel, there…

FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify […]

Read More
1 2