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FDA improves access to reports of adverse drug reactions worldpharmanews
September 29, 2017
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS).
FDA Accepts Supplemental NDA for Lenvatinib as Liver Cancer Treatment americanpharmaceuticacreview
September 28, 2017
There is no guarantee that any investigational uses of such FDA-approved product will gain FDA approval.
FDA Announces Support Plans for Puerto Rico americanpharmaceuticacreview
September 28, 2017
First and foremost, these efforts are focused around our mission driven responsibilities to ensure the safety of the medical products, blood and the food supply needed by residents of the island.
FDA pointedly rejects Intellipharma’s opioid painkiller pharmafile
September 27, 2017
The FDA has been very public in its stance that it will look to gain the upper hand in bringing the opioid epidemic under control, within its own remit.
FDA conducts major global operation to protect consumers from potentially dangerous prescription dru worldpharmanews
September 27, 2017
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines
Allergan Receives Refusal to File Letter from FDA for Vraylar americanpharmaceuticacreview
September 26, 2017
Upon its preliminary review, FDA determined that the sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review.
Medtronic’s next generation spinal cord stimulator cleared by FDA biospectrumasia
September 21, 2017
The world's smallest SCS, the Intellis device offers activity tracking and personalized pain relief
GlaxoSmithKline, needing a sales surge, wins FDA nod for $1B-plus prospect Trelegy fiercepharma
September 20, 2017
Bracing for generic competition to its top-selling Advair, GlaxoSmithKline nabbed an FDA approval for the "closed-triple" COPD therapy Trelegy Ellipta.
Roche added to the hold group by FDA for combo immunotherapy trials pharmafile
September 20, 2017
The FDA has been working to make sure certain immunotherapy trials being placed on full or partial hold.
Review of 2017 H1 of the biological & pharmaceutical industries en-cphi.cn
September 19, 2017
New drug approval reached a historic high, while industry M&A boom fell back

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