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October 3, 2022

Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019

Session Recordings Speakers Keynote: CDER’s Commitment to Pharmaceutical Quality Patrizia Cavazzoni Deputy Center Director for Operations CDER The Importance of Quality in Our Medicines Michael Kopcha […]
October 3, 2022

FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld

Update [10/3/2022] FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld […]
October 3, 2022

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

Docket Number: FDA-2013-N-1434 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Tablets and capsules are widely manufactured and prescribed and may provide a […]
October 3, 2022

Rare Disease Endpoint Advancement Pilot Program

Introduction FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development for drugs that treat rare diseases. The RDEA […]
October 3, 2022

FDA Expands CDER NextGen Portal

[10/3/2022] FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions to FDA under section 505G of the Federal […]
October 3, 2022

Moderna Refused China Request to Reveal Vaccine Technology Moderna Refused China Request to Reveal Vaccine Technology

(Reuters) – Moderna Inc has refused to hand over to China the core intellectual property behind the development of its COVID-19 vaccine, leading to a collapse […]
October 3, 2022

Amylyx Prices Newly Approved ALS Drug at $158,000 Per Year Amylyx Prices Newly Approved ALS Drug at $158,000 Per Year

(Reuters) – Amylyx Pharmaceuticals Inc on Friday set the list price of its newly approved drug to treat amyotrophic lateral sclerosis (ALS) at about $158,000 per […]
October 3, 2022

Latest information and updates about Evusheld for PrEP for COVID-19

FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld Update [10/3/2022] FDA added important information to the authorized Fact […]
October 3, 2022

Will AI Affect the Burden of Surveillance After Polyp Removal? Will AI Affect the Burden of Surveillance After Polyp Removal?

While the use of artificial intelligence (AI) during colonoscopy may contribute to improved cancer prevention, it may also add to patient burden in terms of increased […]
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