article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. That sterile injectables may be more vulnerable to supply change disruptions is not a novel concept.

Drugs 59
article thumbnail

When the Attorney General Talks (Cannabis), People Listen

FDA Law Blog: Biosimilars

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. Attorneys in August 2013 that DOJ was unlikely to take enforcement action against marijuana-related businesses operating in compliance with state law unless the businesses implicated any one of eight enforcement priorities. 29, 2013), 3. 1, 2023 ( 02:38:46 ).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Testimonials are not necessarily representative of all of those who will use our products. Some of our testimonials are provided by customers who have received promotional offers in exchange for their participation. The testimonials displayed are given verbatim except for correction of grammatical or typing errors. 2012.11.002.

Disease 52
article thumbnail

A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law Blog: Biosimilars

In a landmark 2013 decision , a unanimous Supreme Court held that a naturally occurring DNA segment, even when isolated, is a product of nature and therefore does not meet the subject matter eligibility requirement for patentability.

article thumbnail

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40
article thumbnail

Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Agency IQ

PAHPA has been reauthorized several times since its original passage, including as the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). In the 2013 version, the second “P” stood for “Preparedness.”

FDA 40
article thumbnail

Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. 2013) (Kavanaugh, J.). Moreover, all three articles appear to have been covertly generated for litigation purposes, as the lead author for the articles has also acted as an “expert” witness in other abortion-related litigation. FDA , 715 F.3d

FDA 59