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FDA

Showing 15 posts of 1445 posts found.

fdaoutsideweb

FDA weighs in to improve generic competition

June 27, 2017
Medical Communications, Sales and Marketing FDA, generic drugs, pricing debate

Since Scott Gottlieb was appointed Commissioner, the FDA has been on a marked push to tackle two areas: drug pricing …

News

Pfizer’s biosimilar gets a second knock-back from FDA

June 23, 2017
Medical Communications, Sales and Marketing Amgen, Epogen, FDA, Pfizer

Pfizer has been dealt a stinging blow by the FDA, after it received a second complete response letter from the …

News

FDA’s Gottlieb draws those ‘gaming’ system into pricing debate

June 22, 2017
Medical Communications, Sales and Marketing Drug pricing, FDA, Trump

President Trump spoke often of how pharmaceutical companies were ‘getting away with murder’, in regards to drug pricing, and now …

News
fda2outsideweb

FDA locks down import from 3 Indian IPCA facilities

June 21, 2017
Manufacturing and Production, Research and Development FDA, India, Ipca

More drama in the Indian pharma sector as the FDA announces it has enforced a ban on the import of …

News
microscope-275984_960_720

FDA-approved drugs in combination could provide new antibiotics

June 21, 2017
Research and Development Antibiotics, FDA, antibiotic resistance

Research emerging from the University of Utah Health has built on knowledge that drugs used in combination can be more …

News
fda2outsideweb

FDA fast-tracks Pfizer and Lilly’s chronic pain drug

June 15, 2017
Research and Development, Sales and Marketing Eli Lilly, FDA, Pfizer

Pfizer and Eli Lilly are celebrating the FDA’s decision to grant fast-track designation to their joint venture tanezumab in the …

News
pharma_pill_manufacturing

EMA lags behind FDA on continuous manufacturing regulation

June 15, 2017
Manufacturing and Production EMA, FDA, continuous manufacturing

Continuous manufacturing is increasingly an area of fixation within the pharma industry for the benefits it can bring to the …

News

FDA to review effectiveness of abuse deterrent opioid drugs

June 14, 2017
Research and Development, Sales and Marketing FDA, Scott Gottlieb, opioid, opioid crisis

FDA Commissioner Scott Gottlieb continues his fightback against the US opioid crisis after requesting an unprecedented recall of Endo Pharmaceuticals’ …

News
fda_building

FDA calls for withdrawal of opioid product for first time in history

June 9, 2017
Medical Communications Endo pharmaceuticals, FDA, Scott Gottlieb

The FDA, since the appointment of Scott Gottlieb as commissioner, has made strong noises about tackling the opioid crisis and …

News
fdaoutsideweb

FDA approves first generic versions of Lilly’s ADHD drug

May 31, 2017
Research and Development, Sales and Marketing ADHD, Apotex, Aurobindo, FDA, Glenmark, Teva

The FDA has given its approval for the commercialisation of the first-ever generic versions of Eli Lilly’s Strattera (atomoxetine) for …

News

Glenmark greenlighted to market hypertension generic in US

May 30, 2017
Manufacturing and Production, Sales and Marketing FDA, Glenmark, generic, hypertension

Glenmark Pharmaceuticals has revealed it has been awarded final approval by the FDA to market hypertension treatment nebivolol, a generic …

News
novartis_outside_1

FDA approves Novartis’ Zykadia as first-line lung cancer treatment

May 30, 2017
Manufacturing and Production, Sales and Marketing FDA, NSCLC, Novartis

The FDA has announced it has approved Novartis’ Zykadia (ceritinib) as a first line treatment in the expanded indication of …

News

New FDA Commissioner reveals strategy to drive down drug prices

May 26, 2017
Manufacturing and Production, Sales and Marketing FDA, Scott Gottlieb, Trump, pricing

Deregulation, faster access and cheaper drug prices very quickly became the rallying cry for the Trump administration in the life …

News
abbottweb

26 die after attempting to replace Abbott’s blood pump controller themselves

May 24, 2017
Medical Communications, Sales and Marketing Abbott, FDA, Medical device, deaths

At least 26 advanced heart failure patients have died and 19 have been injured by attempting to change the controller …

News
scott_gottlieb

Opioid crisis “highest initial priority” for new FDA Commissioner

May 24, 2017
Medical Communications, Research and Development FDA, Scott Gottlieb, opioid, opioid crisis

Scott Gottlieb, the newly appointment FDA Commissioner, has indicated that his first priority is to tackle the opioid crisis currently …

News
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