Latest News
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22 May 2013
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More than a few Warning Letters sent by the US Food and Drug Administration (FDA) over the years have referenced products that tried to skirt regulation by presenting themselves to regulators as a
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Latest News
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21 May 2013
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The US Food and Drug Administration (FDA) has released a copy of a warning letter sent last week to German pharmaceutical manufacturer Boehringer-Ingelheim, citing alleged manufacturing deficiencies
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Regulatory Update
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20 May 2013
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The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must
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Latest News
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17 May 2013
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The European Medicines Agency (EMA) has announced its adoption of the International Conference on Harmonisation's (ICH) M7 guideline on controlling carcinogenic risk in pharmaceutical products when
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Latest News
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16 May 2013
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The US Food and Drug Administration (FDA) may be at the forefront of trying to prevent the misuse and abuse of opioid painkillers, but as two Federal Register notices this week point out, it's not the
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Latest News
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16 May 2013
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Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and
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Latest News
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15 May 2013
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Regulators with the US Food and Drug Administration (FDA) announced on Tuesday the approval of Arbor Pharmaceuticals' drug Nymalize (nimodipine), a drug intended to treat brain hemorrhaging in
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Latest News
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14 May 2013
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The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two
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Latest News
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13 May 2013
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In a surprising move, the US Food and Drug Administration (FDA) on 10 May 2013 announced that it would permit generic competition to Endo Pharmaceuticals' generic pain pill Opana ER (oxymorphone
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Latest News
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9 May 2013
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Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the
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