The Pharma Data

AUGUST 31, 2020

We found that during the Ebola outbreak in 2014, many people died because of Ebola but not due to Ebola. Many African governments had severe challenges with the procurement of essential supplies to support their response activities and face stiff competition with the more industrialized countries for the limited available supplies. “

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. The new board members are: Dr. Karen J.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

NOVEMBER 9, 2020

Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Eur Respir J 2014; 43: 343–73. NPJ Prim Care Respir Med 2014; 12; 24: 14009. 2014; 133: 388–94. 9 Price D, Fletcher M, van der Molen T.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here. In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE But there are still a couple of possibilities lurking out there! The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s PTE applications were submitted to FDA for each of U.S. RE 44,599 and U.S.

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014.

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The Pharma Data

DECEMBER 21, 2020

Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2014; 43 (2): 343-373. Amgen’s business may be impacted by government investigations, litigation and product liability claims. Eur Respir J.

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