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

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Last month, the FDA released a draft guidance document suggesting investigators should stop using double blind, randomized clinical trials with placebo products, when developing treatments for certain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’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

FDA publishes list of branded drug companies blocking generic competition

As part of the Trump administration’s efforts to address rising drug prices in the US, the FDA has recently published a list of brand name companies which have been using delaying tactics to actively block generic drug competition. FDA commissioner, Scott Gottlieb, has claimed that the purpose of this new initiative is not to shame [...]

By | 2018-08-10T05:32:15+00:00 May 18th, 2018|FDA, Reference Listed Drug|Comments Off on FDA publishes list of branded drug companies blocking generic competition

FDA accepts partial responsibility for high drug prices

Last month, FDA commissioner, Scott Gottlieb, touched on the agency’s shortcomings which have partly contributed to rising drug prices in the US. Speaking at a pharmaceutical event for pharmacy benefit managers in Washington, Gottlieb claimed that many entities are to blame for the skyrocketing drug prices patients are now facing, but that the FDA does [...]

By | 2018-08-10T05:34:11+00:00 May 8th, 2018|FDA, Reference Listed Drug|Comments Off on FDA accepts partial responsibility for high drug prices

The CREATES Act not passed as part of US budget plan

President Donald Trump has recently released his budget plan, and many within the healthcare sector are disappointed to see that The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, has been left out. This bill promises to increase competition and lower prescription drug prices, by eliminating abusive delay tactics [...]

By | 2018-03-07T11:28:03+00:00 February 13th, 2018|Drug Manufacturers, Legislation, Reference Listed Drug|Comments Off on The CREATES Act not passed as part of US budget plan

Repurposing generic and off-patent drugs

As healthcare costs around the world continue to rise, regulators are working on developing solutions that will help provide reliable and more affordable treatment options for patients. One such solution is drug repurposing, which involves finding additional uses for already approved drug products. Because a commercially available drug has already been created, repurposing efforts involve [...]

By | 2018-03-07T11:31:03+00:00 February 9th, 2018|Reference Listed Drug|Comments Off on Repurposing generic and off-patent drugs

Repurposing generic and off-patent drugs

As healthcare costs around the world continue to rise, regulators are working on developing solutions that will help provide reliable and more affordable treatment options for patients. One such solution is drug repurposing, which involves finding additional uses for already approved drug products. Because a commercially available drug has already been created, repurposing efforts involve [...]

By | 2018-03-07T11:37:28+00:00 February 9th, 2018|Reference Listed Drug|Comments Off on Repurposing generic and off-patent drugs