Quality/GMPs

The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.

Drug manufacturers can improve use of quality agreements in contract manufacturing.

Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.

Process validation is an extension of biologics development processes.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

The agency has approved a new HIV treatment for patients with "limited treatment options".

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.

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The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.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