The Lachman Blog

25
Mar

Will the Crunch Be On?

On Tuesday March 24, 2020, Prime Minister Narenda Modi of India ordered an extensive lockdown of all of its 1.3 billion residents.  “There will be a total ban of coming out of your homes,’’ Mr. Modi said. “Every district, every lane, every village will be under lockdown,’’ he said.  “If you can’t handle these 21 […]

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24
Mar

In Times of Crisis, Cyber Threats Increase – Be Wary

As the coronavirus spreads around the globe, unfortunately so do cyber-criminal attacks.  Cyber criminals see this as a golden opportunity to capitalize.  Hackers leverage the panic, confusion, and misinformation to transmit malware, breach computer networks, set up malicious websites, and launch social engineering attacks. Early on in the coronavirus pandemic, the Cybersecurity and Infrastructure Security […]

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23
Mar

A Break from COVID 19 – The Nitrosamine Saga Is Far from Over

Remember the days when the biggest concern that both consumers and the pharmaceutical industry had was about potential contamination of medications by nitrosamines? Just a few weeks ago, rumors were flying around fast and furiously among patient groups on social media, firms were issuing recalls of numerous medications, and regulators were involved in issuing policies […]

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23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

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21
Mar

ADE Relief During Pandemic – But Only if You Need It!

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency.  The FDA issued this Guidance directly with no public comment on March 20, 2020.  It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

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20
Mar

COVID-19 Guidances to Bypass Initial Public Comment Period

In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID […]

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18
Mar

Mission Critical Only Inspections Starting on March 19

On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]

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