The Lachman Blog

18
Mar

COVID-19 and Impact for Ongoing Clinical Trials – FDA Provides Guidance

With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]

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18
Mar

The Art of Filing NDA/ANDA Post-Approval Changes to the FDA

Contract Pharma recently published an article addressing some valuable tips to make your trip along the regulatory pathway to report manufacturing changes easier. The author, Amy Schutte, Senior Associate, Regulatory Practice of Lachman Consultants says, “Change is inevitable, continuous, and reportable to the FDA when we are talking about approved human or animal drugs.” Specifically, […]

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17
Mar

Hand Sanitizer Relief – A Compounders’ Guide to A Safe and  Effective Product

In response to the COVID-19 pandemic, FDA released guidance on March 14, 2020 allowing state licensed pharmacies, compounders, and certain federal facilities (referred to collectively as compounders) to manufacture hand sanitizers. In this guidance, FDA indicated that they are aware of people making their own sanitizers due to the shortage of sanitizers on the market, […]

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17
Mar

Flow Restrictor Recommendations for Oral Liquid Products

Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers.  We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well.  Most of us think […]

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13
Mar

Coronavirus Readiness

  As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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