A Biotech Sector Primer
Investing in biotechs can involve major gains or huge losses. Learn about the industry that focuses on novel drug development ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
As AI Transforms Drug Development, FDA Is Scrambling to Figure Out Guardrails
Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...
medtechdive21d
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...
Forbes9mon
FDA Report Reveals 300% Increase In Cannabis Research Over The Last Decade—Key Findings
“The FDA believes the drug development and approval process represents the best way to ensure that safe and effective new medicines are available to patients in need of appropriate medical therap ...
Hosted on MSN7mon
Supreme Court medication abortion case threatens ‘seismic shift’ in FDA drug approval process, experts warn
“And without necessary investment, drug development would freeze ... but that if the court instead upholds the appeals court decision, the FDA could seek to essentially redo the process of broadening ...
Physicians Committee9d
InSphero and FDA Scientists Publish Benchmark Study for Drug Safety Assessment
Researchers used a scalable human liver microtissue model to accurately predict the drug-induced liver injury concern of 152 ...
Medscape2y
Dermatology Clinical Trials and Drug Development
In contrast, drugs in development for cancers or some immunological ... Efforts to expedite the drug review process at the FDA have allowed patients more timely access to new pharmaceuticals.
Benzinga.com2y
FDA Calendar
What is an FDA ... in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug ...
FDA issues warning to pet companies for selling unapproved antibiotics
"First, these products haven't been through the FDA drug review process, and we don't know ... important antimicrobials contributes to the development of antimicrobial resistance, which affects ...
GlobalData on MSN7d
FDA grants fast track status to FELIQS’s FLQ-101 to prevent ROP
The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP) ...
New York Post19d
Thousands of bottles of common antidepressant Cymbalta recalled by FDA over cancer-causing chemical
FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in ...