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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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Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing...

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FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care...

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Savings accounts: In or out? The CJEU's flexible approach to savings accounts.

In a very short judgment the CJEU has decided that an online direct savings account which permits unlimited access to funds, but only through an intermediate reference (current) account, is ...

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UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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Addressing Implementation: Messages From The FCA Workshop on its Approach to Consumers

The FCA held a workshop last week on Customers in Vulnerable Circumstances which focused on its approach to ensuring inclusive and fair treatment of vulnerable consumers in the financial...

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FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are...

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