Los Angeles is a sprawling metropolis known for being the go-to spot for careers in film and industry. However, beyond the glam of Hollywood, Los Angeles is also the home…
Photo: Irfan Khan/Los Angeles Times/Polaris
Madison Dabalos, 18, left, and Ixchel Cisneros, 18, wearing face masks walk back to their dorms takeout breakfast from Gastronome at Cal State Fullerton on Aug. 21, 2020.
Photo: Irfan Khan/Los Angeles Times/Polaris
Madison Dabalos, 18, left, and Ixchel Cisneros, 18, wearing face masks walk back to their dorms takeout breakfast from Gastronome at Cal State Fullerton on Aug. 21, 2020.
January 15, 2021
The U.S. Department of Education released $21.2 billion Thursday as part of the coronavirus relief legislation Congress and President Trump approved in December to help colleges and universities nationally. Of that amount, more than $2.83 billion will go to public and private California colleges and universities.
Najib Babul Discusses the Use of Fentanyl Test Strips as a Harm Reduction Strategy to Prevent Opioid Overdose Deaths phoenixherald.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from phoenixherald.com Daily Mail and Mail on Sunday newspapers.
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CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the 505(b)(2) regulatory pathway. What are 505(b)(2) new drug applications (NDAs) and do they really provide a meaningful advantage to pharmaceutical companies? Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses the benefits and limitations of this drug approval pathway.
The term 505(b)(2) is derived from Section 505 of the Federal Food, Drug and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984. The latter is informally known as the Hatch-Waxman Act, so named after its legislative sponsors, Representative Henry Waxman of California and Senator Orrin Hatch of Utah. Section 505(b)(2) refers to NDAs for whom some of the information required for approval comes from sources other than the applicant, or for which the appl