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(2) 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 ....
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 generat ....
Cinergen: Najib Babul: On the Accuracy of Acute Pain Recall CLARK COUNTY, NV / ACCESSWIRE / January 5, 2021 / The accuracy of pain recall has important implications for both clinical trials and clinical management where pain is a prominent or primary outcome measure or symptom. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses the accuracy of remembered pain and the benefits and limitations of relying on patient s memory for pain. His conclusion, as reported in peer-reviewed medical journals is that patient recollection of acute pain is generally quite reliable. Pain is a major public health problem, resulting in personal suffering, reduced productivity, and increased health care costs. A report from the Institute of Medicine Committee on Advancing Pain Research, Care, and Education states that chronic pain affects approximately 100 million adults in the U.S. and costs the economy over $600 billion annually. This includes $300 bil ....