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FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

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The European Commission releases an updated Borderline Manual for medical devices

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is...

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Hogan Lovells Publications

FDA guidance may ease path to biosimilar interchangeability

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to...

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Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding "Competition enforcement in the pharmaceutical sector (2009-2017)" ("Report")....

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South Africa's green rush- "weeding" out the confusion

Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...

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The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines...

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EMA office in Amsterdam opened – Wooden shoes, orphan drugs and drug pricing in the context of Brexit

On 9 January 2019, the European Medicines Agency (EMA) opened its office in Amsterdam, the Netherlands. As the UK will leave the EU 29 March 2019 due to Brexit, the EMA is relocating from...

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Hogan Lovells Publications

Pharma companies may benefit from proposed patent law changes in China; public comment invited

On 4 January, China's National People's Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to...

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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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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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