Insights

20
Apr
2017

How will the upcoming CE changes affect the European Union?

The 'CE' mark for biotechnology and medical devices has long been an attractive goal for companies large and small to enter the European market.
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24
Mar
2017

The Procalcitonin (PCT) Assay Got Approval from FDA to Control Unnecessary Antibiotic Use

The increase in antibiotic resistance is becoming an alarming concern in medical science and practice.
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20
Mar
2017

Mutual Recognition Agreement on GMP facility Inspections: new framework for the United States and the European Union

The United States and the EU have agreed to amend the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement (MRA), allowing the US and the EU to utilize each other's good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.
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09
Mar
2017

Programmable synthetic lineage-control network may be the next step in diabetic regenerative medicine

Diabetes affects 380 million people worldwide and, due to the lifestyle in many industrialized nations, the number of sufferers is expected to double by 2030.
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15
Feb
2017

Amendments to regulations governing medical devices in the EU

This EU regulation is drafted with the purpose of smooth functioning of the medical devices market within the EU, with the aim of ensuring greater health protection for patients and especially considering the needs of the small and medium sized enterprises (SMEs) in the medical device sector.
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10
Feb
2017

The Chaos of the Sick Heart

Questioning the efficacy and safety of anti-fibrillation drugs is not an idle academic subject.
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26
Jan
2017

The Controversial Association of Chlamydophila Pneumoniae Infection With Heart Disease

A possibly important causal contributor to CHD has fallen out of clinical consideration because of dramatically negative clinical trial results.
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18
Jan
2017

Challenges and opportunities for orphan drug development and commercialization: US and EU perspective

Addressing the differences and expanding the similarities can improve the alignment in the regulatory requirements in the US and the EU, and is expected to result in greater cooperation in the orphan drug development and approval process.
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12
Jan
2017

Regulatory Environment for Cell and Gene Therapies

Globalization of the medical industry poses a significant challenge for the pharmaceutical companies as drug approval is often delayed and is cost intensive due to the diversity in the regulatory requirements of different regions/countries.
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31
Aug
2016

Defining Data Integrity, Classifying Co-Crystals: New FDA Guidance

There are two items I would like to discuss today. The first is the increased attention that the FDA is paying to data integrity issues and the second is the new FDA guideline on Co-Crystals.
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09
Aug
2016

Protecting IP: What Should Medical Marijuana Suppliers Do?

You have invested considerable man-hours and capital in your grow, extraction/infusion, and dispensing facilities. They are protected by a sophisticated security system and insured. Your employees, vendors, subcontractors, and partners have all been screened—including local and state background checks.
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25
Apr
2016

FDA Approval and Patent Protection of Medical Marijuana: What Would It Take?

For many, the concepts of FDA Approval and patent protection may seem oddly out-of-place in a discussion of medical marijuana.
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11
Mar
2016

Record New FDA Approvals in 2015, But is That a Guarantee?

According to a recent FDA report, their Center for Drug Evaluation and Research (CDER) approved 45 novel drugs in calendar year 2015.
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11
Mar
2016

New EU Clinical Trial Regulations Coming. Are You Ready?

In March of 2016, regulators within the European Union (EU) have approved a new clinical trial initiative designed to quicken the approval process for promising new drugs that address medical needs that are otherwise currently unmet.
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