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Search posts on Warning Letters and 483s

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Shredded Files

Data Integrity 101: Why is it Important?

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology, and medical device firms. Repercussions have included new products not being approved, rescinded approval of products on the market, closure of manufacturing plants, massive product recalls, FDA import alerts, and drug shortages.

Seoul Skyline

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

At the FDA/Xavier PharmaLink conference held virtually in March 2020, AbbVie’s Debra Webb shared her experiences and provided expert advice on navigating the various processes in several APAC markets. Webb discussed her experiences with queries from various agencies during the drug approval process and provides a case study on a post-approval change in South Korea.

Frozen Lobster Tails

Q2 2020 Roundup: Warning Letters to Food & Dietary Supplement Firms

The COVID-19 pandemic dominated news headlines in Q2. This naturally seeped into the FDA’s food and dietary supplement Warning Letters for the quarter. FDA issued a number of Warning Letters to dietary supplement firms for statements that certain products could prevent, treat, or cure COVID-19. In addition, FDA also issued Warning Letters to food and dietary supplement companies for Foreign Supplier Verification Program (FSVP), CGMPs, misbranded/adulterated products, and more.

Globe Showing Asia Pacific Countries

How to Get Products Approved in Asia-Pacific Markets

The Asia-Pacific (APAC) region is known to be a diverse region with respect to languages, religion, culture, and economics. It is also heterogeneous with respect to requirements for new drug approvals. Many countries have their own specific requirements. Understanding the product approval landscape and country-specific nuances can be challenging but is necessary to get drug products approved in APAC countries.

Cat Getting a Vaccine

Comments Due Oct 15 for Animal Bulk Drug Compounding Guidance

Director of CVM’s Office of Surveillance and Compliance Tim Schell provided details on his office’s 2020 accomplishments and insights into the guidance, Compounding Animal Drugs from Bulk Drug Substances (BDS) at the 2020 PDA/FDA Joint Regulatory Conference held virtually in mid-September.

RECENT POSTS

Shredded Files

Data Integrity 101: Why is it Important?

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology, and medical device firms. Repercussions have included new products not being approved, rescinded approval of products on the market, closure of manufacturing plants, massive product recalls, FDA import alerts, and drug shortages.

Read More »
Seoul Skyline

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

At the FDA/Xavier PharmaLink conference held virtually in March 2020, AbbVie’s Debra Webb shared her experiences and provided expert advice on navigating the various processes in several APAC markets. Webb discussed her experiences with queries from various agencies during the drug approval process and provides a case study on a post-approval change in South Korea.

Read More »

RECENT POSTS

Shredded Files

Data Integrity 101: Why is it Important?

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology, and medical device firms. Repercussions have included new products not being approved, rescinded approval of products on the market, closure of manufacturing plants, massive product recalls, FDA import alerts, and drug shortages.

Read More »
Seoul Skyline

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

At the FDA/Xavier PharmaLink conference held virtually in March 2020, AbbVie’s Debra Webb shared her experiences and provided expert advice on navigating the various processes in several APAC markets. Webb discussed her experiences with queries from various agencies during the drug approval process and provides a case study on a post-approval change in South Korea.

Read More »