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INDUSTRY RESOURCES

08
Oct
Batch Testing And Brexit: 4 Things You Need To Know

The U.K. has until March 29, 2019 to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario,including recently introduced new guidelines for the batch testing of medicines entering or leaving the U.K.

Posted in:Clinical,Manufacturing,
05
Oct
Continuous Manufacturing: Why Isn’t It Ubiquitous Yet? (When It Should Be)

The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.

Posted in:Manufacturing,
04
Oct
Auditor Evaluations: A GMP Auditing Best Practice

Auditing programs perhaps implicitly provide feedback at the reporting stage of an audit. Most companies and third-party auditing programs conduct a technical review of completed audit reports.

Posted in:Manufacturing,
04
Oct
State Of The Cell And Gene Therapy Sector — Clinical, Financial, And Regulatory Perspectives

The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.

Posted in:Clinical,Manufacturing,R&D,
Tags:ARM,cell and gene,cell therapy,medicine,regenerative,
03
Oct
What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan

In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilar products. When FDA Commissioner Scott Gottlieb introduced the BAP, he emphasized the importance of building a market for biosimilar products and expressed concern that the market is not yet established.

Posted in:FDA,
01
Oct
Risk Mitigation Strategies For Compounding Pharmacy Operations

With the 2018 Compounding Policy Priorities Plan, the FDA has established a clear pathway for advancement of policies for traditional compounding pharmacies and associated outsourcing facilities. The agency intends to implement the strategies while ensuring access to medications for the critical patient population. It is acting under the belief that a growing number of organizations are trying to get into the large drug manufacturers’ domain while operating under pharmacy licenses.

Posted in:FDA,Manufacturing,

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