Quality/GMPs

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA enforcement efforts and drug approvals trend upward.

Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.

Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

The President described US drug costs as unfair and stated that prices will come down.

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.

Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.

As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.

The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.

The latest continuing resolution funds the government for three weeks.

The FDA center released its list of planned guidance documents for the rest of the year.