Quality Systems

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

Experts weigh in on trends in the biotechnology market, psychedelics, and India.

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

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.

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

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care.

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

The most safe and effective therapies demand the highest data quality.

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