The FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. We are unable to determine whether the number of such Warning Letters issued during the entire year represents a significant increase over 2022.

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Roots Analysis

FEBRUARY 27, 2024

We have identified different strategies for different types of companies: Transformers: Invest heavily to enhance market leadership Aggressively acquire companies and look for new opportunities Leaders: Focus on core strengths. The post COVID-19 and Recession: Identifying Long-Term Growth Opportunities appeared first on Blog.

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Board Vitals - Pharmacist

JUNE 14, 2018

These questions are divided into categories so you can assess your strength and weaknesses based on topics. The post Important Considerations to Help You Pass the NCLEX-RN® appeared first on BoardVitals Blog.

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The FDA Law Blog

SEPTEMBER 15, 2022

Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products. FDA interprets the regulation for drug products without an established name (generally monograph drug products do not have an established name) as requiring the name of the active ingredient, the pharmacological category, and strength. (The

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The FDA Law Blog

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. The final guidance stresses the importance of ensuring that an HCP can understand the “strength/limitations of the CDS software recommendations.”. software or labeling.

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Roots Analysis

FEBRUARY 21, 2024

Broadly, wearable exoskeleton market can be classified into two major categories, namely medical and non-medical exoskeletons. The post Industrial and Medical Exoskeleton: Current Landscape and Future Market Outlook appeared first on Blog. For detailed insights about this domain, check out our report on medical exoskeleton market.

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The FDA Law Blog

OCTOBER 2, 2023

Several of these approvals, including examples in which we were directly involved—Relyvrio for ALS and Skyclarys for Friedreich’s Ataxia—expanded upon the examples FDA previously provided to illustrate their interpretation of the single study plus confirmatory evidence statutory standard (see our earlier blog posts here and here ).

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