FDA Biotech Proposal Draws Criticism

From The Hill: The Food and Drug Administration (FDA) plans to require biotech companies to give drugs more specific names, but the plan to add suffixes has drawn criticism across the industry. Recently, the FDA released a draft guidance calling for the addition of suffixes to names of biologics and biosimilars Biosimilars are similar versions[…]

Trump Looking to Trump State Laws?

Previously, White House Press Secretary Sean Spicer commented that the Trump administration plans to crack down on legalized Cannabis. The Justice Department, head by Attorney General Jeff Sessions, reiterated his unfriendly Cannabis stance. Sessions did note that Medical Marijuana would not be targeted by officials but that he would review current policies. It did not[…]

Emerald Cup Cracks Down on Contaminated Cannabis

The Emerald Cup is the oldest and most prominent of the various Cannabis cups, but now is becoming a trendsetter in another regard. Tim Blake, the co-founder of the California-based Emerald Cup realized change was necessary when the cup developed a problem with contaminated Cannabis. The cup’s roots are self-identified as hippie. Growers are supposed[…]

NDI Guidance Would Weaken Supplement Industry According to Jarrow Formulas

The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas. The Food and Drug Administration (FDA) first issued the NDI guidance in 2011 in an effort to further define the regulations set in the Dietary Supplement Health and Education Act of 1994 (DSHEA)[…]

UK Pharma Industry Bracing for Possible Disruption

From FierceBiotech: GlaxoSmithKline CEO Andrew Witty fears that if the European Medicines Agency (EMA) is moved from London, it will cause a tremendous disruption for the UK’s pharma and biotech industry. Experts worry about the possibility of regulatory upheaval if Brexit happens. The fate of the EMA is in the air. Brexit is currently in[…]

Louisiana Drug and Supplement Maker Ordered to Stop Production by Courts

Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with[…]

CBD’s State Regulation Conundrum

Unlike the Pacific Northwest and New England, southern states have been slow to pass pro-Cannabis legislation. Several states have voted to approve Cannabidiol (CBD) for very specific conditions and have granted licenses to research organizations, as well as some businesses – but patients face a conundrum. While patients with a qualifying medical condition are allowed[…]

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Will Brexit and Trump Affect Future Pharmaceutical Packaging and Labeling Regulations?

The Pharmaceutical industry is gradually coming into compliance with new regulatory requirements including the Falsified Medicines Directive (FMD) for Britain and the Drug Supply Chain Security Act (DSCSA) for the US. An important deadline coming up in November 2017 mandates that manufacturers must include product identifiers, serial numbers, lot numbers, and expiration dates in their[…]

The Importance of Quality Agreements

While using third-party contract manufacturers has become a common trend in the pharmaceutical and biotech industry, it is not without risk. The practice supposedly keeps costs down by avoiding equipment, validation, personnel and other production expenses leaving the burden of following Good Manufacturing Practices (GMPs) on the contract manufacturer, but this may not always be[…]