Regulatory Oversight and Compliance

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.

The European Medicines Agency plans on using existing patient registries to collect information on medicines.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

Managing change and overcoming employee resistance and fear requires a proactive approach.

An integrated approach can improve the efficiency of cleaning validation studies.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

The agency releases guidance on controlled correspondences related to generic-drug development.

Exports and domestic market have each been valued at more than US$15 billion.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?