ANDAs

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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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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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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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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24
Feb
October Approvals

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here).  A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]

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20
Feb
Linked together in logistics

Regulatory Affairs and the CMO Factor

The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed.  While the use of a […]

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