Regulatory Oversight and Compliance

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

FDA struggles to track shortages caused by a rise in demand.

Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Unique dosage forms, personalized medicine, and flexible manufacturing are possible with 3DP.

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

Health crises, political tension, and budget concerns were major challenges.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

NMPA has approved Ferinject in China for the treatment of iron deficiency or iron deficiency anemia.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

The DGA seeks to increase trust in data sharing, strengthen mechanisms to make data more available, and overcome obstacles to the reuse of data, which are vital ingredients to the intersectoral use of health data.

FDA keeps its user fees but fails to gain important reforms.

Industry experts discuss best practices for certificates of analysis.

New medications show exciting outcomes for weight loss.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.