Our last post on the Eleventh Circuit’s September 2021 decision in Catalyst v. Becerra got a lot of attention. We’d like to think that this is because the scope of orphan drug exclusivity is as fascinating to everyone as it is to us, but if …
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Month: April 2022
- Higher and Higher (Into the Fire): Jacobus Appeals Orphan Drug Case to SCOTUSApril 21st, 2022
- “It’s In the Mail” Will Soon No Longer Apply to DEA Registration ApplicationsApril 20th, 2022
Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically. DEA issued a final rule on April 11, 2022, eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more …
- Animal Drug Compounding from Bulk Substances and FDA’s Release of GFI # 256: Is or Is Not the Third Time a Charm?April 19th, 2022
On April 13, 2022, FDA released its long-anticipated final Guidance for Industry # 256 – Compounding Animal Drugs from Bulk Drug Substances (GFI). As readers of this blog likely remember, the animal drug compounding GFI has had a relatively long and tortured history, blogged about …
- Highlights from FDA’s Draft MDUFA V Commitment LetterApril 15th, 2022
On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA authorizes FDA to collect fees from certain medical device applicants …
- ACI’s 17th Annual Paragraph IV Disputes Conference (In-Person and Livestream)April 14th, 2022
The American Conference Institute (“ACI”) is hosting its 17th Annual Paragraph IV Disputes Conference in New York (and livestream) from April 26-27, 2022 (Eastern Daylight Time). Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and …
- More of a Bad Thing? Thoughts on FDA’s Proposal to Extend the FDR Process to Withdrawals of Accelerated ApprovalsApril 13th, 2022
On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget. This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. …
- Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the EstimationApril 12th, 2022
One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. This estimation …
- James R. Phelps: 1938 – 2022April 4th, 2022
With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan and Nicola, …
- Not An April Fool’s Joke: California BOP Establishes Loss Reporting ThresholdsApril 4th, 2022
Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates …
- CMS Releases Guidance on Multiple Best Price Reporting for Value Based ArrangementsApril 1st, 2022
In January 2021, we reported on a CMS rule that, among other things, revised the Medicaid rebate best price regulation to remove impediments to value-based purchasing (VBP) arrangements in Medicaid. The rule, which will go into effect on July 1, 2022, defined a VBP is …