Quality & compliance
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Learn MoreThe long and winding road for quality metrics takes another turn
In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).
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Learn MoreThreading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products
This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...
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Learn MoreEarly Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting
Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...
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Learn MoreThe Evolving Cell and Gene Therapy (CGT) Sector in China
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Learn MoreNever Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities
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Learn MoreHow Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House
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Learn MoreFive points to remember if FDA issues a Form 483
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View NowCase Study Achieving Product Endorsement after a FDA Warning Letter
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Compliance Consulting Services Brochure for Law Firms
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Learn MoreI Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19
On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...
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Learn MoreAn overview of the recent Executive Order on Critical Drugs Made in America
On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...
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View NowHow to interact virtually with health authorities
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Learn MoreGxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...
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Learn MoreWill the FDA “CARE” More About Your Supply Chain?
On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...
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Learn MoreHas EMA started a domino effect for more regulation of API manufacturing?
On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...
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Learn MoreWhat’s Around the Corner for FDA Inspections?
There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...
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Risk Mitigation and Compliance Consulting Brochure for BioPharma Companies
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Learn MoreFDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices. Numerous...
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Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
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Learn MoreKeeping ahead of the regulatory curve – Stay open for business
On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...
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