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
Najib Babul Discusses the Benefits and Limitations of the 505(B)(2) Regulatory Pathway For Drug Approval pittsburghstar.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pittsburghstar.com Daily Mail and Mail on Sunday newspapers.
Press release content from Accesswire. The AP news staff was not involved in its creation.
Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis
January 8, 2021 GMT
CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / Erythropoietic protoporphyria (EPP) is a devastating lifelong disorder characterized by dermal photosensitivity with only one recently approved treatment and very few evidence-based clinical management tools. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses this serious debilitating condition.
EPP is a rare inherited disorder of heme biosynthesis characterized by dermal photosensitivity secondary to a partial deficiency of ferrochelatase. In a phenotypically similar X-linked protoporphyria (XLP), there is overactivity of the heme biosynthesis enzyme, erythropoietic aminolevulinate synthase (ALAS2). Both EPP and XLP result in the accumulation of the photosensitizer protoporphyrin IX (PPIX) in erythro
Cinergen: Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis
CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / Erythropoietic protoporphyria (EPP) is a devastating lifelong disorder characterized by dermal photosensitivity with only one recently approved treatment and very few evidence-based clinical management tools. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses this serious debilitating condition.
EPP is a rare inherited disorder of heme biosynthesis characterized by dermal photosensitivity secondary to a partial deficiency of ferrochelatase. In a phenotypically similar X-linked protoporphyria (XLP), there is overactivity of the heme biosynthesis enzyme, erythropoietic aminolevulinate synthase (ALAS2). Both EPP and XLP result in the accumulation of the photosensitizer protoporphyrin IX (PPIX) in erythrocytes, plasma, skin and liver. The accumulated PPIX is activated by sun exposure, thus generating free