Regulatory Oversight and Compliance

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

The author reviews FDA's final Animal Rule guidance.

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

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

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

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

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

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

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

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.

BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

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

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

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

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

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

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.