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Brexit: Prepare for the worst and hope for the best: Implications for banking, payments and consumer finance products

To ensure the financial system continues to work effectively if there is a "hard Brexit" HM Treasury has been finalising a series of statutory instruments which will ensure there is a...

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And who are you? EBA Opinion on the use of eIDAS certificates under PSD2

The EBA has published an Opinion dated 10 December 2018 on the use of eIDAS certificates under PSD2. The EBA has taken the step to issue an Opinion to ensure consistent implementation as...

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FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Earlier today, FDA published its finalized Data Integrity Guidance. The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and...

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Four new FDA guidances and proposed rule advance biosimilars policy framework

Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological...

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It's just around the corner - Further steps along the journey to developing a compliant dedicated interface

On 4 December the EBA published its Final Report on the Guidelines on the conditions to benefit from an exemption from the contingency mechanism under Article 33(6) of the RTS on SCA &...

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China takes significant steps to consolidate generic drug industry and lower prices

On 7 December, China announced its newly implemented pilot centralized drug procurement program will cut prices for certain off-patent generic drugs by up to 96%. Under the program, China...

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FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators...

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Are we nearly there yet? Further steps along the journey to developing a compliant dedicated interface for TPP access

On 9 November the API Evaluation Group published its long awaited statement of recommended functionalities for the APIs banks and other payment service providers – ASPSPs- will be...

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And another one… the draft Brexit amendments to the Payment Accounts Regulations

In the midst of the raft of Brexit related statutory instruments being published by the government in recent weeks, HM Treasury has published a draft version of the Payment Accounts...

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The FOS regime – changes in scope – some you win, some you lose!

The FCA has recently published its plans to extend the scope of the FOS regime and also to increase the compensation awards which can be made.

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12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful...

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