AbbVie’s Imbruvica fails to meet main goal in pancreatic cancer study

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

For example, the agency will not issue a Form FDA 482 or a Form FDA 483 during the course of remote interactive evaluation. Background. With…

Breaking Down FDA’s New Remote Monitoring Strategy

The observations, however, will not be issued on a Form FDA 483 and will not be considered inspectional observations. The agency does request, …

FDA blasts Colombian drug manufacturer in warning letter for not properly addressing API flaws

But that’s exactly how a Colombian API maker responded following a Form 483, and now the agency is reading the riot act. The FDA issued…

An Introduction To Trending In Environmental Monitoring Programs

An FDA 483 observation dated May 2, 2014 stated that “[REDACTED] Water trending records are not always accurate or supported by raw data.

Form 424B5 Aptorum Group Ltd

… or sufficiently respond to an FDA Form 483 or subsequent Warning Letter, this could impair our ability to market our products in a cost-effective…

Bristol Myers scales up cell therapy production with liso-cel nod in hand and another approval …

The therapy had a circuitous road to its FDA nod, including a series of manufacturing snafus at a Lonza Houston contract site that led to…

Iris Recognition in Access Control Market Trends, Analysis, Demand and Global Industry Research …

Download FREE sample copy of Iris Recognition in Access Control market report @ https://www.reportsanddata.com/sample-enquiry-form/483 …

EAS Due Diligence Assessments Support Private Equity and Venture Capital Firms with …

… DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services, due diligence assessments, or support after receipt of a FDA form 483 …

Form 8-K Biohaven Pharmaceutical For: Mar 17

… manufactured or distributed by the Company (“Applicable Laws”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, …

Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success

The Form 483 documents the regulatory clause(s) that is violated for the audited project and is informally provided to the team involved in the inspection …

Latest Posts

Brazil coronavirus deaths climb to 46,510, cases near 1 million

By Admin

Brazil recorded 1,269 additional COVID-19 deaths on Wednesday, bringing its official death toll from the novel coronavirus to 46,510, the most in the world outside...

Comments closed

Requiring masks ‘political hazard’ as COVID-19 surges in California breadbasket

By Admin

The first wave of COVID-19 came slowly to San Joaquin County in the heart of California's breadbasket, but the much-feared second surge is roaring through,...

Comments closed

Mothers as ‘trauma surgeons:’ the anguish of raising black boys in America

By Admin

Raising black boys in America involves "constant mental anguish," Danielle Pattillo, a special education teacher in New York City and mother to two sons, ages...

Comments closed

Record spike in new coronavirus cases reported in six U.S. states as reopening accelerates

By Admin

New coronavirus infections hit record highs in six U.S. states on Tuesday, marking a rising tide of cases for a second consecutive week as most...

Comments closed

Some Amazon villagers eschew drugs for COVID-19, take ‘toothache plant’ herbal tea

By Admin

Some villagers in the eastern Amazon are spurning Brazilian government advice to take the malaria drug hydroxychloroquine to keep the novel coronavirus at bay and...

Comments closed

AbbVie Inc said on Friday its blockbuster cancer treatment in combination with chemotherapy agents failed to meet the main goal in a late-stage study of patients with a form of pancreatic cancer.

Also Read: Sanofi and GSK to join forces in vaccine collaboration to fight COVID-19