By Riëtte van Laack – Last week, FDA announced its final rule regarding over-the-counter (OTC) consumer antiseptic wash products. As we reported in 2013, FDA issued a proposal to declare all antimicrobial consumer hand wash products as not generally recognized as safe and effective but invited comments …
By Riette Van Laack – On June 30, as required under the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA published the amended tentative final monograph for consumer antiseptic rubs, also referred to as consumer rubs, leave …
By Kurt R. Karst – There are general life certitudes, such as the quote attributed to Benjamin Franklin: “In this world nothing can be said to be certain, except death and taxes.” There are also FDA certitudes we’ve come to recognize. For example, “everything eventually goes generic” …
By Riëtte van Laack – As required by the Sunscreen Innovation Act (SIA), FDA published its proposal for the review of Time and Extent Applications (TEAs) for non-sunscreen ingredients (the SIA lays out the framework for sunscreen ingredients). It now is evident that a TEA will …
By Riëtte van Laack – In 2002, FDA issued regulations providing for a process, the Time and Extent Application (TEA), to create a new Over-the-Counter (OTC) drug monograph or amend an existing monograph to recognize that an active ingredient or condition (e.g., dosage form) is Generally …
By Riëtte van Laack - As we previously reported, FDA and FTC are reviewing their regulation of homeopathic drugs. In March 2015, FDA issued a notice requesting comments on the current use of homeopathic drugs, and that agency’s approach to regulation of the category. In June 2015, FTC …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By Wes Siegner – FDA held a public hearing titled “Homeopathic Product Regulation” on April 20 and 21 of this year. Now the FTC has announced that it will hold a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21. FDA’s Federal Register Notice …
By Kurt R. Karst – We like simplicity. After all, it is, as Leonardo da Vinci reportedly once said, “the ultimate sophistication.” We also like simple FDA-related legislation; but that’s not something we see all too often. (We also don’t often see legislation addressing Prescription-to-Over-the-Counter (“Rc-to-OTC”) …
By Riëtte van Laack – Continuing its broad application of the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA issued a proposal to amend the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter …
By Kurt R. Karst – Late last month, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a Writ of Certiorari (Case No. 14-751) with the U.S. Supreme Court asking the …
By Riëtte van Laack – The House of Representatives on Nov. 13 unanimously passed the Senate version of the Sunscreen Innovation Act (SIA), S. 2141. The Act is currently before the President, who is expected to sign it. The SIA amends the Food, Drug, and Cosmetic …
By Kurt R. Karst – In a September 30, 2014 decision, a unanimous panel of judges from the U.S. Court of Appeals for the Ninth Circuit affirmed an August 2013 decision from the U.S. District Court for the Northern District of California finding that a first-in-the-nation …
By Kurt R. Karst – The so-called “drug lag” – i.e., the difference (or perceived difference some might say) in drug availability between the United States and other countries – was one of myriad reasons some folks back in the early 1990s thought it was necessary …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
