On July 10th, FDA announced its goal of restarting domestic on-site inspections beginning the week of July 20th. The regions of the U.S. that will be on the receiving end of these inspections are those that the agency’s rating system demonstrates are the safest for …
Back in the Spring, one of the first COVID-related guidances FDA issued was on the conduct of clinical trials during the COVID-19 emergency. This guidance was updated with a Q & A section just a week later (see our blog posts here and here) and …
Initially enacted in 2012 and reauthorized for the first time in 2017, the Generic Drug User Fee Act (“GDUFA”) was adopted to accelerate access to safe and improve the predictability of the generic drug review process. FDA touts the GDUFA as a “remarkable success” that …
Notwithstanding FDA’s earlier efforts touting the benefits of outsourcing facility registration, here, there are less than 75 registered facilities. Almost the same number of outsourcing facilities have opened – and shut – their doors since the passage of the 2013 Drug Quality and Security Act …
In recent months, the Food and Drug Administration (FDA) has issued a record number of Emergency Use Authorizations (EUAs) under Section 564 of the Federal, Food, Drug, and Cosmetic Act (FDCA). With a large number also pending, this review pathway is becoming almost common for …
CMS Proposed MDRP regulation: In the Federal Register of Friday, June 19, CMS published a proposed rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. …
It has been over three months since FDA issued its press releases stating that it was postponing most foreign and domestic facility surveillance inspections (see here and here). Since then, apparently only “mission critical” surveillance inspections have taken place, leaving the bulk of registered facilities …
On Tuesday, June 16, the U.S. Court of Appeals for the District of Columbia Circuit affirmed a district court decision to vacate the May 2019 Drug Price Transparency rule published by the Centers for Medicare & Medicaid Services (CMS). As we reported when the rule …
The Prescription Drug Marketing Act (PDMA) and implementing regulations establish procedures for distributing prescription drug samples, including requirements related to requests, receipts, and recordkeeping. Federal Food, Drug, and Cosmetic Act § 503(d); 21 C.F.R. Part 203. Typically, many drug manufacturers that use drug samples as …
Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has likely been redirected to a new URL: https://outage.regulations.gov/beta-redirect/. And the first thing you see on …
FDA’s recent announcement (see our previous post here) that after 40 years the Orange Book may get a bit of a facelift – as well as a comment in a new draft guidance that folks could obtain prior editions of the Orange Book through the …
FDA issued another COVID-related guidance for immediate implementation last week. Citing a substantial increase in the number of requests for individual patient expanded access requests for COVID-19 investigational drugs (which we will use here to include biological products), on June 2, 2020, FDA released a …
Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020. And why not?!? After all, the Orange Book is celebrating its 40th anniversary this year. There was even a special “BPCIA Orange Book Transition Edition” published in …
Now that most of the country has been in lockdown for about two months, everyone is undoubtedly aware that COVID-19 has been declared an “official” public health emergency. In addition to the official declaration in January, HHS issued an additional and separate declaration – called …
The Pharmaceutical Manufacturing Research Services (“PMRS”) appears to abide by the proverb “If at first you can’t succeed, try try again.” After several denied Citizen Petitions, striking out in the Eastern District of Pennsylvania, and bringing then dismissing another suit against FDA in that same …
