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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU. 2023;113:108-123.

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FDA approves first ever OTC birth control pills

The Checkup by Singlecare

Norgestrel was approved by the FDA for prescription use in 1973 , but it hasn’t been available since 2005 due to business reasons for the manufacturer. In a July 13 statement , Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America, applauded the move: “Birth control is essential health care.

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments.

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Pharma within planetary boundaries

European Pharmaceutical Review

Giving environmental risk assessments teeth Since 2005, the authorisation of a human pharmaceutical product requires an environmental risk assessment (ERA). European Pharmaceutical Strategy – European Commission (draft) Pharmaceutical package. Internet] Berlin: Centre for Planetary Health Policy. Available from: [link].

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2005. Q2(R2) Validation of Analytical Procedures: Text and Methodology.

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Can you drink on Mucinex?

The Checkup by Singlecare

Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In an average adult, the immediate-release forms, like the capsule and liquid, are usually taken every four hours, while the extended-release tablets are typically taken every 12 hours.