Regulatory Oversight and Compliance

The final guidance addresses safety aspects of container and carton labeling design.

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Several steps need be taken to achieve lights-out, fully automated operations.

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The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

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 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.

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.