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Generics vs. Brands: Who is to Blame When Something Goes Wrong?

by Tina LaFonte | Jun 25, 2013 | Adverse Events, Drugs, Labeling, Safety

Introduction Generic drugs become available once a patent expires on a branded drug, which, in the US, is generally 20 years. Generic drugs account for more than 80% of all prescriptions in the US, and since generic drug manufacturers do not incur the same costs as...

Should Dietary Supplements Follow the Same Approval Process as Pharmaceutical Drugs Before Being Put on the Market?

by Tiffany Brooks | Jun 20, 2013 | Adverse Events, FDA, Safety

Introduction Dietary supplements, unlike brand and generic drugs, do not require premarketing approval from the FDA and are considered “unregulated drugs that do not have a consistent dosage from batch to batch.” By law, the FDA must investigate a product if a safety...

Does the Increase in AEs Reported in the VAERS after Vaccine-Related Litigation Misrepresent Vaccine-Caused Injuries?

by Tina LaFonte | Jun 17, 2013 | Adverse Events, Safety

Introduction Vaccines are routinely administered to healthy individuals, primarily infants, with the expectation that they will be protected from certain preventable diseases that often result in severe complications such as pneumonia, infection, meningitis, and...

Compounding Pharmacies: Part 1

by Samantha Ricketts | May 22, 2013 | Compounding, Manufacturing, Safety

What is Compounding? Compounding occurs when a patient comes into the pharmacy and needs a customized formula to meet their individual needs. The pharmacist then creates a mixture of the medication according to directions provided by the prescriber. Who Regulates...

Should Compounding Pharmacies Be Regulated by the FDA instead of State Boards?

by Fazal Chaudhry | May 2, 2013 | Compounding, FDA, Safety

Introduction In the US today, there are many rules and regulations outlined by the Food and Drug Administration (FDA) that pharmaceutical companies must abide by. Even with these rules and strict guidelines, there are companies known as compounding pharmacies that do...

Should the FDA Have the Authority to Enforce Penalties on Improper Needle Disposal?

by Yuqian Liu | Apr 18, 2013 | FDA, Medical Devices, Safety

Introduction     Needle is a class 2 medical device under the regulation of the FDA. Other sharps such as lancets are commonly used medical devices. These devices could be obtained at local community pharmacies behind-the-counter for limited quantities or by...
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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.
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