Election 2016: The Future of Pharma Under Trump

Note: This is not an endorsement of Donald Trump. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Trump, she’s just the author) Republican Presidential nominee Donald Trump released his proposed health care plan that he would[…]

Medical Device Manufacturer Under Consent Decree for Selling Contaminated Product

Pharmaceutical Innovations, Inc. has pleaded guilty to criminal charges stemming from distribution of ultrasound gel that was contaminated with bacteria in an article from Justice News. This ultrasound gel is commonly used for ultrasounds, sonographs, EKGs and other procedures. The company received two misdemeanor counts of introducing an adulterated medical device to interstate commerce. They[…]

Are Art and Design the Future of Biotech?

When you think about biotech and medical devices, do you connect their design with art and design students? Traditionally, tech and devices have been born from the minds of engineers and scientists, but the Biodesign Summit in New York City hosted these students to show off their conceptual designs. Students from Rensselaer Polytechnic Institute designed[…]

How Will UK Drug Regulation Be Affected by Brexit?

Now that the UK has voted to leave the European Union (EU), there are many questions being asked, Tracy Staton of FirePharma pointed out. The UK had been home to the EU’s European Medicines Agency (EMA) for most of their participation in the union, but that is no more with Brexit. The UK’s life sciences[…]

FDA Approves Abbott Absorb First-of-a-Kind Dissolvable Heart Stent

The Food and Drug Administration (FDA) has approved the Abbott Absorb, the first fully-dissolving heart stent in the US. Abbott’s Absorb GT1 is approved and available in over 100 countries outside the US and now has the go-ahead from the FDA. The GT1 Bioresorbable Vascular Scaffold (BVS) System is made from pol(L-lactide), which is a[…]

Medical Marijuana States Have Lower Prescription Drug Use

Shefali Luthra from Kaiser Health News via the Cannabist reports the results of a study conducted by policy experts. States with legalized medical marijuana, which is recommended for epilepsy, chronic pain, and even anxiety, saw a decrease in the number of Medicare prescriptions for drugs used to treat the aforementioned symptoms. The study examined data[…]

USPLabs Wants Experts to Show Safety of Their Dietary Supplements in Felony Prosecution

Josh Long from Natural Product Insider has the scoop on a dietary supplement manufacturer heading to court to defend the safety of its supplement. USPlabs’ tale begins in 2013 after a physician at a hospital in Honolulu filed a report with the Food and Drug Administration’s MedWatch adverse event reporting program (AER). Six patients that[…]

FDA Regulations Coming Soon for 3D Printed Medical Devices?

3-D printed products, Additive Manufacturing (AM) as the technical term, are becoming increasingly popular and commonplace when manufacturing medical devices. Examples of 3-D printed devices include implants, surgical instruments, dental restorations, prosthetics, and much more. It’s forecasted that the 3-D printed medical device market will exceed $21 billion by 2020 according to MDDI’s Device Talk[…]