News & Analysis as of

Inspections Regulatory Oversight

Conyers

Key Insights from Cayman Islands Seminar on CIMA Onsite Inspections

Conyers on

The Financial Services Institute in collaboration with Conyers, Grant Thornton and Cayman Finance hosted its fourth comprehensive training seminar on “Preparing for an Onsite Inspection from the Cayman Islands Monetary...more

Lowndes

Drone Use by Commercial Building Owners

Lowndes on

Owners and buyers of commercial buildings are increasingly using drones also known as unmanned aircraft systems (UAS), to inspect roofs and other exterior elements of buildings. In addition to making it easier to access the...more

Epiq

[Webinar] Competition and regulatory scrutiny in ‘the new normal’ - September 21st, 4:00 pm - 5:00 pm BST

Epiq on

As the Covid-19 pandemic subsides, there is mounting evidence of a shift in approach by regulatory enforcement agencies around the world. Industries that have historically been at lower risk of investigation are coming under...more

Dechert LLP

Litigation Risks in FDA Remote Interactive Evaluations

Dechert LLP on

Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive evaluations.  FDA has since issued a written policy...more

Hogan Lovells

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

Hogan Lovells on

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

Hogan Lovells

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

Hogan Lovells on

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has...more

Morgan Lewis

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

Morgan Lewis on

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more

Hogan Lovells

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

Hogan Lovells on

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more

Mitchell, Williams, Selig, Gates & Woodyard,...

On-Site Civil Inspection Procedures: U.S. Environmental Protection Agency Final Rule

The United States Environmental Protection Agency (“EPA”) issued a final rule on March 2nd that is intended to provide direction to its personnel on how to conduct on-site civil administrative inspections. See 84 Fed. Reg....more

Robinson+Cole Data Privacy + Security Insider

Beyond Visual Line of Sight Drone Operations in Kansas

Last week, the Federal Aviation Administration (FAA) gave the go-ahead for the Kansas Department of Transportation (KDOT) to conduct beyond visual line of sight (BVLOS) drone operations. The KDOT team, which includes Kansas...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

Hogan Lovells on

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Hogan Lovells

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

Hogan Lovells on

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more

Hogan Lovells

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

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