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Child-Resistant Packaging

RX Note

Limitations Child-resistant packaging can present difficulties for some aged individuals or people with disabilities. External Links Perceptions and Attitudes of People with Disabilities and Older Adults about Child-resistant Drug Packaging, 2012 Are child safety caps enough to keep kids out?, How Child Proof Caps Work?

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Frontiers Health Digital Innovators: Aptar’s Sai Shankar

pharmaphorum

He joined Aptar in April 2017, having spent 15 years in big pharma – Allergan (CMC team leader, Head of R&D Packaging development, Product Development) and Sanofi (Packaging Engineering, Industrial Affairs). Sai has 20 years of product development and business strategy experience in the pharmaceutical industry.

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RedX Pharma CEO focuses on pipeline that found Lilly’s rising star

pharmaphorum

Back in 2017, the UK biotech RedX Pharma had to sell its prized asset after administrators stepped in to stave off a debt crisis, with Loxo Oncology snapping up the BTK inhibitor for $40 million.

Packaging 119
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Trick of the Trade: Antibiotic ointment for removal of artificial nail glue from eyelids

ALiEM - Pharm Pearls

Because nail glue is often packaged in small containers identical to eye drop bottles, patients can mistake the nail glue for ophthalmic drops — especially those with visual impairment [6]. Published Apr 12, 2017. Nail glue injuries to the eye: assessment of two cases. Can J Ophthalmol. 2022;57(1):e11-e13. doi: 10.1016/j.jcjo.2021.04.026

Packaging 130
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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Hikma had to start a whole new trial to answer the FDA’s questions following a rejection in 2017 and then had to put its launch on hold this year while the regulator reviewed a packaging update. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Biosimilars

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A.

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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law Blog: Biosimilars

Drug manufacturers have had electronic systems in place since 2017. FDA will exercise enforcement discretion concerning the implementation of the electronic interoperable exchange of information between trading partners to the package level. Guidance at 4. So what is FDA going to do?