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The guidance provides information on review timelines during the COVID-19 pandemic.

FDA Publishes Guidance on CRLs Response Timelines during Pandemic

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.

FDA Issues Guidance on Complex Innovative Trial Designs 

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA Answers COVID-19 Vaccine Questions

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

FDA Advisors Recommend Moderna’s COVID-19 Vaccine

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

FDA Approves First-of-its-Kind Genomically Altered Line of Pigs for Potential Therapeutic Uses

The films are now available in three options of varying thickness for added protection against moisture and oxygen.

ACG Films Expands its Portfolio of Ultra-High Barrier Blister Films

The company has formed an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s COVID-19 vaccine candidate, to the people of Singapore. 

Moderna Enters into Supply Agreement to Provide Singapore with its COVID-19 Vaccine

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.  

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