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Dr Stephen Hahn appointed as new FDA commissioner
Dr Stephen Hahn has been voted into the role of…
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
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Scott Gottlieb
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Macleods Pharmaceuticals issues recall due to NMBA impurities
Macleods has issued a recall of 32 lots of drug…
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
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Former FDA Commissioner joins Pfizer’s board of directors
Former FDA Commissioner, Scott Gottlieb, who stepped down from the…
Former FDA Commissioner, Scott Gottlieb, who stepped down from the administration in April, has joined Pfizer’s board of directors.
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Heart drugs free from carcinogens identified as recalls drag on
The Food and Drug Administration has released a list of…
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
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FDA sends four warning letters for cGMP violations
The US Food and Drug Administration has posted warning letters…
The US Food and Drug Administration has posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (cGMP) regulations...
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Acting FDA Commissioner named
As Dr Scott Gottlieb steps down from his role next…
As Dr Scott Gottlieb steps down from his role next month, Dr Ned Sharpless has been announced as his short-term replacement...
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New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application…
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
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FDA commissioner Scott Gottlieb resigns
Scott Gottlieb has announced that he will resign from the…
Scott Gottlieb has announced that he will resign from the position of commissioner of the US Food and Drug Administration (FDA) at the end of the month...
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FDA finds another carcinogenic impurity in ARB blood pressure drug
FDA is 'deeply concerned' about a third type of nitrosamine…
FDA is 'deeply concerned' about a third type of nitrosamine impurity detected in angiotensin II receptor blocker (ARB) medicines...
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Policy to improve access and foster price competition for generics
A policy has been implemented to aid companies in the…
A policy has been implemented to aid companies in the formulation, production and manufacture of generic drugs, especially when the originals are expensive...
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Programs to promote innovations in drug manufacturing
Innovations in drug manufacturing could result in higher quality drugs…
Innovations in drug manufacturing could result in higher quality drugs at less of the cost, and the FDA is willing to help facilitate this development...
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Generic version of seizure drug Sabril gets FDA approval
A generic version of the seizure drug Sabril (vigabatrin) has…
A generic version of the seizure drug Sabril (vigabatrin) has been approved by the FDA...
