Regulatory/GMP Compliance

The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

The agency sent a warning letter to Genesis II Church for marketing fraudulent chlorine dioxide products the company claims treats and prevents COVID-19.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).

Regulatory emergency planning has been put to the test with the COVID-19 pandemic.

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.

The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.

AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).

Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

Following reports, that are particularly circulating social media, questioning whether non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, worsen COVID-19, the European Medicines Agency (EMA) has issued advice.

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.

This article details the more operational aspects of monograph submissions, answering the question of how to participate.

The authors present a case study with raw materials and excipients, where a consistent, cross-functional approach is needed to ensure the appropriate selection, sourcing, testing, and filing of the materials used to manufacture bio/pharmaceutical products in a global environment, ensuring compliance with applicable compendial and regulatory requirements.

This article summarizes all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. This look into what is on the horizon is important to help companies prepare for the inevitable changes and ensure the continued supply of quality medicines to patients globally.