Pharma
The term pharma is a shortened version of the word pharmaceutical, which can be used to describe medication, its manufacturers, or the associated industry. Pharma is also used as a shortened version of pharmacology, which describes the biomedical science behind pharmaceuticals and their effects on the body.
What Are Pharmaceuticals?
Pharmaceuticals refer to drugs and medications that are used to diagnose, treat, or prevent diseases. These compounds can be derived from natural sources or synthesized in laboratories. Pharmaceuticals are critical in managing health conditions, curing diseases, and promoting overall health and wellness.
Regulation of Pharmaceuticals in the United States
In the United States, the regulation of pharmaceuticals is primarily handled by the Food and Drug Administration (FDA). The FDA ensures that all pharmaceuticals sold in the U.S. meet these critical requirements:
- Safety: Before any new drug can be sold, it must be proven safe through rigorous laboratory testing and clinical trials.
- Efficacy: Pharmaceuticals must demonstrate effectiveness in treating the conditions for which they are marketed.
- Quality: Drugs must be consistent in strength, purity, and quality. This standard is maintained through strict manufacturing oversight and compliance checks.
The FDA’s drug approval process involves several stages, including:
- Preclinical Research: Testing of drugs on animals to assess safety and biological activity.
- Clinical Trials: Drug testing in humans, which occurs in phases to evaluate safety, effectiveness, optimal dosages, and side effects.
- Review and Approval: Submission of a New Drug Application (NDA) containing all testing data for FDA review; if the benefits outweigh the risks, the drug is approved for sale.
International Regulation of Pharmaceuticals
Internationally, the regulation of pharmaceuticals varies by country but generally follows principles similar to those of the FDA. Several international bodies help harmonize regulations across countries:
- European Medicines Agency (EMA): Regulates drugs within the European Union, ensuring safety, efficacy, and quality.
- World Health Organization (WHO): Provides guidelines and standards to improve healthcare worldwide, including the regulation of pharmaceuticals.
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): Brings together regulatory authorities and pharmaceutical industry representatives from multiple regions to discuss scientific and technical aspects of drug registration.
Challenges and Considerations
Regulating pharmaceuticals involves addressing numerous challenges, such as the rise of counterfeit drugs, ethical concerns in drug testing, and the need for expedited approvals for life-saving treatments without compromising safety. Global collaboration and continual improvement in regulatory frameworks are essential to meet these challenges effectively.
Overall, the regulation of pharmaceuticals is a complex but vital component of global healthcare, ensuring that all medications available to the public are safe, effective, and of the highest quality.
Medical Devices and Pharma
Medical Devices and Pharma provides the latest agency information for drug shortages, alerts, and recalls. We also publish information about pharma product innovations and enforcement actions like FDA warning letters to pharma manufacturers. And of course, we cover other news from FDA and global news sources.
Pharma Headlines
Amneal Recalls Vancomycin Hydrochloride Oral Solution
Some bottles may be super potent Attention Patients, Health Professionals, and Pharmacies: Amneal Pharmaceuticals issued a safety notice on March 27 for a recall of specific lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL. This recall has been...
Camber Recalls Atovaquone Oral Suspension USP
Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug...
FDA Approves Lamzede for Treatment of Alpha-mannosidosis
The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme replacement therapy (ERT) for the treatment of rare alpha-mannosidosis, a genetic disorder that affects an individual's ability to break down complex sugars....
FDA Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as...
FDA Warning Letter to Jackson Clinic
Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the Alzheimer's disease treatment Leqembi. This is a significant milestone in the fight against Alzheimer's, a debilitating and progressive brain...
Regulatory Documentation for National and Global Market Access
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Three Companies Recall Blood Pressure Medication
All recalled products had unacceptable levels of nitrosamines Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer...