Quality/GMPs

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

On Feb. 9, 2016, an FDA Arthritis Advisory Committee will meet to discuss a biologics license application (BLA) for CT-P13 (Remsima), a proposed biosimilar to Janssen Biotech's Remicade (infliximab), by South Korea’s Celltrion in partnership with Pfizer. The BLA was submitted via the abbreviated 351(k) pathway and seeks to cover all of the eight indications that are approved for Remicade.

The agency prepares a plan to implement new packaging safety features.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Can the feds negotiate Medicare Part D prices?

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Understanding of the risks associated with FMEA is crucial in lot release testing.

The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

More “me-betters” and more focused breakthroughs could enhance new drug development.

mstay/Getty ImagesBiopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specifi