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FDA to incorporate more of patient experiences and perspective into drug development and review processes

Over the past decade, regulators and healthcare authorities have become increasingly aware of the important role that patients can play in developing new medicines and getting them to market. In light of this, in new legislation in the US, the 21st Century Cures Act, which was passed in December 2016, the FDA has been charged [...]

By | 2018-11-09T07:04:43+00:00 November 9th, 2018|FDA, Legislation|Comments Off on FDA to incorporate more of patient experiences and perspective into drug development and review processes

FDA proposes international standardization for generic drug development and approval

In the US, prescription drug prices are continuing to increase. In response to this, the FDA has come up with new initiatives to improve generic drug development and access. Generic drugs are cheaper alternatives to brand-named products, which increase competition on the market place. Although the FDA does not play a direct role in setting [...]

By | 2018-10-31T06:22:29+00:00 October 31st, 2018|FDA, Reference Listed Drug|Comments Off on FDA proposes international standardization for generic drug development and approval

MHRA publishes proposals for dealing with a no-deal Brexit

In the last remaining months leading up to the UK’s exit from the EU, the Medicines and Healthcare products Regulatory Agency (MHRA) is taking action to prepare for a potential ‘no-deal’ Brexit. The MHRA strongly believes that cooperation between the UK and the EU will be beneficial for both sides and remains hopeful that an [...]

By | 2018-10-09T11:36:27+00:00 October 9th, 2018|Governments, Health|Comments Off on MHRA publishes proposals for dealing with a no-deal Brexit

Pharma companies encouraged to prepare for ‘no-deal’ Brexit

With the Brexit leave date fast approaching, efforts are continuously being made to ensure that patient health and wellbeing remain protected, following the UK’s exit from the EU. Last month, the Secretary of State for Health and Social Care, Matt Hancock, released two letters to the pharmaceutical industry outlining recommended contingency plans for a potential ‘no-deal’ Brexit [...]

By | 2018-09-19T08:56:28+00:00 September 19th, 2018|Health, Legislation|Comments Off on Pharma companies encouraged to prepare for ‘no-deal’ Brexit

Healthcare organizations come together to create new generic drug company

Medicine shortages and rising drug prices continue to plague the US healthcare system, despite efforts being made by government on the national and local level to combat the issue. As it stands, hospitals around the country are finding that they cannot access the products they need and are being forced to bear the brunt of [...]

By | 2018-09-12T08:21:00+00:00 September 12th, 2018|Health, Reference Listed Drug|Comments Off on Healthcare organizations come together to create new generic drug company

FDA suggests avoiding double blind, randomized clinical trials using a placebo for certain types of development programs

Last month, the FDA released a draft guidance document suggesting investigators should stop using double blind, randomized clinical trials with placebo products, when developing treatments for certain malignant hematologic and oncologic diseases. In the three-page document, the agency explains the rationale behind this suggestion and proposes some alternative trial designs. Interested parties now have 60 [...]

By | 2018-09-05T08:46:30+00:00 September 5th, 2018|FDA, Reference Listed Drug|Comments Off on FDA suggests avoiding double blind, randomized clinical trials using a placebo for certain types of development programs

FDA initiates complex innovative trial designs (CID) pilot program

The FDA has recently initiated a pilot program which will help drug manufacturers use complex innovative trial designs (CID). This move comes after the agency committed to helping facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, as part of the sixth iteration of the Prescription Drug User Fee [...]

By | 2018-08-31T10:54:23+00:00 August 31st, 2018|Drug Manufacturers, FDA|Comments Off on FDA initiates complex innovative trial designs (CID) pilot program

Senate goes against White House by proposing $2 billion increase in funding for NIH

In a move that defies President Trump’s proposed budget for fiscal 2019, the Senate is gearing up to approve a $2 billion increase in funding for the National Institutes of Health (NIH). This increase has been proposed as part of the Senate’s “minibus”, which combines the Senate’s Defense bill and its Labor, Education and Health [...]

By | 2018-08-23T06:38:28+00:00 August 23rd, 2018|Health, Legislation|Comments Off on Senate goes against White House by proposing $2 billion increase in funding for NIH

FDA’s Competitive Generic Therapy (CGT) designation

Earlier this week, the FDA approved potassium chloride oral solution which is the first generic drug to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway has been created as part of the FDA’s broader Drug Competition Action Plan. The agency recognizes the important role generic drugs can play in increasing competition and [...]

By | 2018-08-10T09:30:44+00:00 August 10th, 2018|FDA, Reference Listed Drug|Comments Off on FDA’s Competitive Generic Therapy (CGT) designation

FDA releases Biosimilars Action Plan

The US has had a hard time accepting biosimilar drugs, the copycat versions of biologics which are similar to the innovator product, but not exact replicas. To date, the FDA has approved only 11 biosimilar products, while the EMA has approved 25. Furthermore, of the 11 products that have been approved, 8 have been kept [...]

By | 2018-08-02T06:01:37+00:00 August 2nd, 2018|FDA, Reference Listed Drug|Comments Off on FDA releases Biosimilars Action Plan