We recently came into possession of a small stack of Letter Decisions issued by the Exclusivity Board in the Center for Drug Evaluation and Research – the “CDER Exclusivity Board” – and decided that a series of posts on each decision would be an entertaining …
In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years. The letter, issued August 16 to …
Comment one, comment all! As part of FDA’s ongoing effort to clarify the classification for medical device accessories (see our previous posts here, here, and here), on August 17, 2018, FDA issued a notification requesting comments on a proposed list of accessories that FDA believes …
As we previously reported, the most critical issue facing the animal cell cultured industry is a need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction over which aspects of production and distribution. Earlier this year, the discussion heated up …
An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products. This is not a new campaign for Pfizer, who has emphasized the need to address anticompetitive exclusionary practices, “misinformation,” and market …
For regular readers of compounding news on our FDA Lawb Bog, the “bulks” saga for outsourcing facilities continues with a whirlwind of activity. A bit of background: FDA published a new bulk substances list for Section 503B outsourcing facilities on July 23, 2018, where vasopressin somewhat …
One of the most painful consequences of a bad inspection at a U.S. facility is FDA’s resulting refusal to issue certificates to foreign governments (CFGs) until the issues are resolved. CFGs are quite often a requirement to renew licenses and permits to sell in various …
In United States of America ex rel Streck v. Allergan Inc., a federal False Claims Act (FCA) case alleging that several pharmaceutical manufacturers knowingly calculated false Average Manufacturer Prices (AMPs) that affected their Medicaid rebate payments, the U.S. Court of Appeals for the Third Circuit …
In an effort to address, in Attorney General Jeff Sessions’ words, “the worst drug crisis in American history,” the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”), are for the third straight year proposing to reduce the quantity of Schedule II opioid …
Last month, Representatives John Sarbanes (D-MD) and Bill Johnson (R-OH) introduced H.R. 6478, the “Biosimilars Competition Act of 2018.” The bill would amend the Public Health Service Act (“PHS Act”) to require that certain agreements between biosimilar applicants and reference product sponsors be reported to …
On August 13, 2018, Buffalo, New York-based Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC (Athenex) announced the launch of their vasopressin compounded formulation injection ready-to-use product line (see Press Release here). It also moved to intervene (either as of right or permissively) in …
Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics. We have written about this topic multiple times (see our list at the end of this post). The focus of many …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 32nd iteration – is scheduled to take place from September 26-28, 2018, at the Omni Parker House, in Boston, Massachusetts. The conference is billed as the premier event to provide folks with …
As readers of this blog know, the Agricultural Marketing Service of the USDA (AMS) is mandated to implement the 2016 National Bioengineered Food Disclosure Standard (“NBFDS” or the “Standard”). Congress set a time line for AMS to take certain actions toward implementing the Standard. AMS, …
Well, we haven’t quite waited the lifetime that Foreigner did, but it’s exciting nonetheless. Only about one year after signing the provisions into law, FDA announced the approval of the first generic drug with a Competitive Generic Therapy (“CGT”) designation: ANDA 211067 for potassium chloride …
