Keeps.SU- Pharmaceutical Knowledge Base - Page 2

Manufacturing Deficiencies: Common FDA Quality Issues in Pharma and Medical Devices

Manufacturing Deficiencies: Common FDA Quality Issues in Pharma and Medical Devices

The FDA is cracking down on manufacturing deficiencies in pharma and medical devices, with rising warnings over aseptic failures, data fraud, and poor quality culture. Learn the top issues and what companies must fix to stay compliant.

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Wearable ECGs for QT Safety: Real-Time Risk Detection

Wearable ECGs for QT Safety: Real-Time Risk Detection

Wearable ECG devices like the Apple Watch and KardiaMobile 6L now enable real-time QT interval monitoring, helping detect dangerous heart rhythm risks before they become emergencies - especially for patients on high-risk medications.

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Serious Adverse Events: Reporting Procedures for Generic Drugs

Serious Adverse Events: Reporting Procedures for Generic Drugs

Serious adverse events from generic drugs are underreported despite identical FDA rules. Learn why the system fails, how to report correctly, and what’s being done to fix the safety gap.

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Fertility and Thyroid Health: What Your TSH Levels Should Be Before Trying to Conceive

Fertility and Thyroid Health: What Your TSH Levels Should Be Before Trying to Conceive

Optimizing TSH levels before conception is critical for fertility and healthy pregnancy outcomes. Learn why a TSH under 2.5 mIU/L is recommended, how Hashimoto’s changes the target, and what steps to take now to protect your future pregnancy.

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Gastrointestinal Combination Products: What Generics Are Available and What Alternatives Exist?

Gastrointestinal Combination Products: What Generics Are Available and What Alternatives Exist?

Learn which gastrointestinal combination products have generic versions, what alternatives exist when they don’t, and how to navigate insurance restrictions for better, cheaper care.

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FDA Facility Inspections: How the Agency Ensures Quality in Manufacturing

FDA Facility Inspections: How the Agency Ensures Quality in Manufacturing

The FDA inspects thousands of facilities each year to ensure drugs, devices, and food are made safely. Learn how inspections work, what they look for, and how to prepare to avoid costly failures.

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Black Box Warnings: What You Need to Know About the FDA’s Strongest Drug Safety Alerts

Black Box Warnings: What You Need to Know About the FDA’s Strongest Drug Safety Alerts

Black box warnings are the FDA's strongest safety alerts for prescription drugs, signaling serious or life-threatening risks. Learn what they mean, how they work, and what you should do if your medication has one.

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Hyperthyroidism: How Beta-Blockers Manage Overactive Thyroid Symptoms

Hyperthyroidism: How Beta-Blockers Manage Overactive Thyroid Symptoms

Beta-blockers like propranolol provide fast relief from hyperthyroidism symptoms such as rapid heartbeat, tremors, and anxiety. They don't cure the condition but are essential while long-term treatments take effect.

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Generic Drug Labeling Requirements: What the FDA Mandates in 2026

Generic Drug Labeling Requirements: What the FDA Mandates in 2026

The FDA requires generic drug labels to match brand-name drugs exactly, with only minor exceptions. Learn what’s mandated, why delays happen, and how new rules are fixing safety gaps in 2026.

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Nonalcoholic Fatty Liver Disease and Gut Health: How Diet and Weight Loss Can Reverse It

Nonalcoholic Fatty Liver Disease and Gut Health: How Diet and Weight Loss Can Reverse It

Discover how diet and weight loss can reverse nonalcoholic fatty liver disease by healing your gut and reducing liver fat. Learn what to eat, what to avoid, and why probiotics alone won’t fix it.

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