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Cinergen: Najib Babul Discusses the Benefits and Limitations of the 505(B)(2) Regulatory Pathway For Drug Approval


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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 ....

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Wi-Fi Alliance launches certification for 6E devices


Jan 7, 2021 5:11pm
IDC expects Wi-Fi 6E will see rapid adoption in 2021, with more than 338 million devices entering the market. Smartphones, PCs and laptops will be in the first wave.(Getty Images)
The Wi-Fi Alliance announced that its certification program for Wi-Fi 6E is now available to deliver interoperability for devices operating in the 6 GHz spectrum.
In the U.S., the FCC last year voted to open 1,200 megahertz of 6 GHz spectrum for unlicensed uses, and since then, global momentum for Wi-Fi at 6 GHz is increasing every day, according to Kevin Robinson, SVP of Marketing at the Wi-Fi Alliance. Traditionally in the U.S., Wi-Fi has operated in the 2.4 and 5 GHz bands. ....

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Power generation companies seek scrapping of NERC


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Power generation companies (Gencos) yesterday called for the scrapping of the Nigerian Electricity Regulatory Commission (NERC), describing the industry’s regulator as weak and unable to perform its duty.
They said despite the powers bestowed upon the commission, indiscipline and contract breaches were still pervading the electricity supply space with the regulator refusing to act at all or taking decisions late.
In the latest biannual bulletin, published by the Gencos, the Executive Director of the Association of Power Generation Companies of Nigeria (APGC), umbrella body of the over 20 generators in the country, Dr. Joy Ogaji, advocated an “independent and transparent regulator.” ....

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NYSE U-turns on delisting China's telecoms


NYSE U-turns on delisting China s telecoms
By MA SI and ZHOU LANXU |
China Daily |
Updated: 2021-01-06 08:19
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Signs of China Telecom, China Mobile and China Unicom are seen during the China International Import Expo (CIIE) at the National Exhibition and Convention Center in Shanghai, on Nov 5, 2018. [Photo/Agencies]
United States govt urged to do more to protect rights, interests of investors
China called on the United States government to do more to protect the legitimate rights and interests of investors, after the New York Stock Exchange said it no longer intends to move forward with the delisting of three Chinese telecom carriers. ....

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