Quality Systems

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.

The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

Recent trends in dissolution testing have led to increased use of data integrity solutions and more biorelevant testing techniques.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.