FDA published a notice requesting information on how consumers use plant-based products whose names include terms such as “milk,” “yogurt,” and “cheese,” and how consumers understand those terms when used in such product names. The notice seeks data and evidence in five major areas, namely: (A) the …
FDA announced the establishment of a new policy that provides for the release of lists of retailers that may have received a food subject to a recall. Historically, FDA has not released such information because it is considered confidential commercial information. FDA now has concluded that …
CDER recently published a new Manual of Policies and Procedures (MAPP 5014.1) for the site selection model used by CDER staff to prioritize manufacturing sites for routine cGMP inspections. The goal of the changes associated with the MAPP is to promote the effective and efficient …
FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 …
Hyman, Phelps & McNamara, P.C.’s James Valentine is serving as a speaker for DIA’s Measuring Impact in Patient-Centered Drug Development Conference, which will take place October 2-3, 2018 in North Bethesda, Maryland. DIA’s Measuring Impact in Patient-Centered Drug Development Conference is designed to help sponsor companies …
In the words of the inimitable Yogi Berra: “When you come to a fork in the road, take it.” Last month the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) proposed significant reductions of Schedule II opioid pain medication quantities to be manufactured …
This is the second post in a series of posts dedicated to delving into and discussing various issues that arise with both 5-year New Chemical Entity (“NCE”) exclusivity and 3-year new clinical investigation exclusivity based on a small stack of Letter Decisions we obtained that …
In a memo issued by the Attorney General to all civil litigators throughout the country, AG Sessions set forth the DOJ position that it would seek to limit courts from applying “overbroad injunctive relief” in cases involving “nationwide injunctions.” A “nationwide injunction” is one in …
A few months ago we reported on FDA’s recent enforcement efforts targeting electronic nicotine delivery systems (ENDS), such as e-cigarettes, and warned that the Agency is watching retailers and manufacturers closely (see here and here). In a September 12, 2018 announcement, FDA summarized its enforcement efforts …
After submitting five Citizen Petitions to FDA since 2016 (see Docket Nos. FDA-2018-P-2851; FDA-2017-P-4352; FDA-2017-P-3064; FDA-2017-P-1359; FDA-2016-P-0645) alleging that evidence does not support approval of opioids, Pharmaceutical Manufacturing Research Services (“PMRS”) is trying a new tactic to challenge FDA’s regulatory scheme for abuse-deterrent opioids: court. PMRS …
One of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as such,” including …
On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to. The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a …
On Sept. 10, 2018, the Food Safety Inspection Service (FSIS) of the USDA and FDA announced a joint public hearing scheduled for Oct. 23-24, 2018. The federal register announcement, explains that this will follow a meeting by FDA’s Science Advisory Board on October 22, 2018. The …
As we celebrate the 35th Anniversary of the Orphan Drug Act (see our 30th anniversary post here), periodic consideration of opportunities to reform and refine the approach to rare disease medical product regulation is warranted – similar to the review that occurred 10 years ago, which …
Back in June 2017, we introduced folks to a system we dubbed “ANDA Arbitrage.” It’s an effort undertaken by a company called ANDA Repository, LLC to help companies potentially decrease annual user fee liability under the second iteration of the Generic Drug User Fee Amendments …
