FDA Law

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers.

Supply Chain 52

Supply Chain Provider Government Complication 52

FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

Manufacturing 52

Manufacturing Government IT Complication 52

FDA Law

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. This all sounds complicated, I know. Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).

Provider 59

Provider IT Manufacturing Complication 59

FDA Law

JULY 13, 2022

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. Patent settlements, by their nature, incentivize competition by providing a date certain for entry before patent expiration. Each product is limited to two years of delay. On the final condition, it’s not clear what “incentivizes.

IT 52

IT Manufacturing Utilities Complication 52

GeriPal

JANUARY 11, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Yeah.

Illness 144

Illness IT Medical Provider 144

FDA Law

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. The catch is, as we have learned from the GSK v.

IT 52

IT Provider ER Insurance 52