article thumbnail

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.

article thumbnail

Health Highlights, Dec. 10, 2020

The Pharma Data

. “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

Delveinsight

Food and Drug Administration has given a green signal to the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia. . Welcome the First Generic of Drug for Severe Hypoglycemia.

Trials 52
article thumbnail

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

article thumbnail

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

article thumbnail

MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.

article thumbnail

Disrupted medical conferences: 2022 and beyond

pharmaphorum

Moreover, no attendee data was available for physical symposia, whereas all virtual symposia packages provided full attendee metrics analyses. Accessibility to physical symposia was limited to approximately one hour, compared with three years on-demand for virtual symposia, or 26,280 times longer.

Doctors 98