Obscured last week amidst the tumultuous passage of tax reform, Congress urged the Drug Enforcement Administration (“DEA”) in a bipartisan letter to quickly update its regulations and guidance on the partial filling of schedule II controlled substance prescriptions. The letter notes that “[l]arge amounts of …
The U.S. Court of Appeals for the Second Circuit issued a decision a couple of weeks ago reversing the conspiracy conviction of a defendant for distribution of unapproved drugs, among other things. The trial court had rejected evidence relating to an advice-of-counsel defense asserted by the …
In 2007, Congress determined that the public health would be adequately protected if manufacturers and importers of lower risk class I and II medical devices provided summary quarterly reporting of malfunctions to FDA. This system would replace the more burdensome approach of requiring individual 30‑day …
On December 18, FDA released its draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” This is the latest guidance from the Agency on the relationship between in vitro diagnostic (IVD) products and therapeutic products. You will recall that the Centers jointly issued the …
On December 18, 2017, FDA announced the availability of a new draft guidance for homeopathic drugs. This guidance, when finalized, will replace the compliance policy guide (CPG) 400.400 from 1988. Homeopathy is based on an 18th-century idea that substances that cause disease symptoms can, in very small …
As discussed previously, the Organic Livestock and Poultry Practices (OLPP) rule has a somewhat tortured history. The rule was finalized at the end of the Obama administration. Since then, USDA’s Agricultural Marketing Service (AMS) has delayed the effective date of the rule several times, most …
On December 8, 2017, the pharmaceutical manufacturers’ trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), filed a complaint in federal district court in the Eastern District of California seeking declaratory and injunctive relief against implementation and enforcement of California’s recently enacted California Senate Bill …
On November 29, 2017, CDRH issued two draft guidances regarding CLIA Waiver requests: “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1998 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” (CLIA Waiver Guidance) and “Recommendations for Dual 510(k) and CLIA Waiver …
FDA recently published a guidance document reminding proponents of GRAS status of their obligations under the FFDCA and its implementing regulations (which we refer to as the “Reminder Guidance,” available here). FDA also published a draft guidance document setting out best practices for convening a …
The Drug Enforcement Administration (“DEA”), in response to the nationwide controlled pharmaceutical diversion and abuse crisis, now conducts more frequent regulatory inspections in greater depth to identify registrants who violate the Controlled Substances Act and implementing regulations. In addition to inspecting and auditing manufacturers, distributors, …
As readers of this blog may recall (see here), the purpose of the Sunscreen Innovation Act (SIA) was to speed up FDA’s review of time and extent applications (TEAs). TEA process provides a pathway for adding an active ingredient to an existing over-the-counter (OTC) drug …
The field of digital health is relatively new and is growing fast. Because many uses of software for health‑related purposes are within the statutory definition of a medical device, the Food and Drug Administration (FDA) is a major player in determining how digital health will …
“For Americans under the age of 50, drug overdoses are now the leading cause of death.” DOJ, Attorney General Jeff Sessions Delivers Remarks Announcing New Tools to Combat the Opioid Crisis (Nov. 29, 2017) (here). “With evidence suggesting that nearly 80 percent of individuals addicted …
On November 16, 2017, FDA released a comprehensive policy framework for how the Agency intends to apply existing laws and regulations that govern regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). The policy framework is set forth in a series …
On November 16, 2017, FDA released four guidance documents that, together, the Agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). The policy framework is set forth …
