The agency's ambitions were fueled in part by external criticism. The barbs that stung most sharply were ones suggesting a certain indifference on the FDA's part.
The agency denied Pain Therapeutics' and Durect's abuse-deterrent opioid in a complete response letter after warning the drugmakers about how they promoted the drug.
The OPDP sent its second untitled letter this week, this time to Durect and Pain Therapeutics over the presentation of Remoxy ER.
The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee's meeting on Wednesday.
The regulator charged Celator Pharmaceuticals with promoting an experimental drug as safe and effective even though it has not been approved.
The FDA will hold a public hearing in November to gather input on how it should regulate certain off-label communications.
PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.
The FDA expands use for Pfizer's Prevnar 13 vaccine; an FDA panel votes in support of Novartis biosimilar; U.S. healthcare spending rises 5.5% in 2015
Purdue Pharma reportedly knew about OxyContin trafficking; Amgen's Repatha approved for monthly dosing option; Clinton proposes new healthcare measures
The FDA said Amgen's biosimilar of Humira is safe and effective; Juno trial halted due to patient deaths; the CMS bans Theranos founder
Former FDA commissioners said agency should be independent from HHS; Sanofi and BI confirm asset swap; FDA panel to vote on new Jardiance data
Brexit votes creates EU regulatory uncertainty; Obama plans to veto health saving accounts bill; broad Entresto adoption could prevent more than 28,000 deaths
Medicare cost-cutting panel will not be activated this year; more Americans are abusing opioids; BIO blasts ICER
A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer
Lawmaker calls for investigation of Purdue; Jazz to acquire Celator; Intercept's liver drug is approved
The FDA accepts Samsung's biosimilar for review; Sanofi retools executive committee; Entresto may get a boost from updated care guidelines
E.U. lifts warning on Pfizer's Chantix; Obama's Medicare Part B proposal panned by lawmakers; France to propose stricter rules for clinical trials
Pharma companies took issue with the methodology for the FDA's proposed studies of advertising tactics.
Advertising lobbyist said eliminating the DTC ad tax deduction is a real threat to the industry.
The FDA issues warning for certain antipsychotics; Shkreli may face more securities charges; Genentech and Stand Up to Cancer launch campaign
Pfizer settles rebate suit; Sanofi moves to acquire Medivation; AstraZeneca sells US rights to gout drug
The Senate committee on Aging said Valeant's missteps go beyond price hikes and that its business model is fundamentally to blame.
Pearson expected to say price hikes were too aggressive; Collegium's painkiller receives full FDA approval; most hospitals stop advertising infant formula
FDA panel says Duchenne drug is not effective; Bill Ackman to appear before Senate committee investigating pricing issues; Daiichi Sankyo to open new headquarters
Sanofi is reportedly interested in buying Medivation; Sean Parker funds $250 million cancer research institute; FDA will review Merck's allergy biologic
The FDA advisory committee voted 12-1 against approving the therapy, citing safety issues and requesting more data.
California bill would require price disclosures; AbbVie's and Genentech's blood-cancer drug is approved; FDA expands metformin use
Analysts have estimated the drug could reach $2 billion in sales in the next four years.
The FTC asks for more info about Pfizer-Allergan deal; the FDA loosens guidelines for abortion-inducing drug; startup to deliver Truvada through an app
The American College of Physicians questioned the role direct-to-consumer advertising plays in contributing to prescription drug costs.
Lawmakers call out high price of Xtandi; Novo Nordisk breaks ground in North Carolina; Sanofi poaches top research scientist from AstraZeneca
A jury ruled in favor of Amgen, saying its patents for Repatha are valid.
The FDA will prioritize certain generic drug applications; Valeant posts fourth-quarter loss; medical marijuana drug shines in Phase-III trial
The agency has proposed two studies to investigate the use of superimposed text and the use of animated characters.
Amarin settles with the FDA over off-label promotion suit; mobile apps often share medical information with third parties; drug spending rose 12% in 2014
The proposed legislation would forbid drugmakers from writing off advertising as a tax deduction.
New PhRMA CEO issues policy strategy; study assess patient response to immuno-oncology drugs; Twitter may be an effective way to talk about clinical trials
Senate approves Califf as FDA commissioner; one-fifth of published trial data is used for "marketing trials;" Valeant CEO Pearson is on the mend
The Senate clears Califf; Sanofi files new drug application for Lantus/Lyxumia combination; the FDA approves UCB's new epilepsy drug
Lawmaker seeks to stop DTC ads for newly approved drugs; testosterone therapy helps sexual function; the FDA requests more data about Catalyst's rare drug
SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes
Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog
A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."
The FDA plans to release new guidance on advertising in 2016; Trump supports Medicare price negotiations; Novartis CEO: golden days of drug pricing are over
The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.
HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.
Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.
One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."
Valeant receives subpoenas over drug pricing; BMS signs new immuno-oncology deal with Five Prime Therapeutics; Pfizer CEO says insurance coverage to blame in price debate
Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner
Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death
Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue
An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.
Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy
PhRMA hires Ubl as CEO; two drugs report superior results in kidney-cancer trials compared to the standard of care; Novo Nordisk's shares rise on Tresiba approval
The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.
New analysis says Paxil is not safe or effective for teens; some FDA reviewers voted against Addyi approval over side effects; HHS partners with AstraZeneca on antibiotic development
Obama nominates Robert Califf as FDA commissioner; The Huffington Post debuts investigative series on J&J; Amgen acquires cholesterol-lowering drug
Amarin begins legally promoting off-label uses of its prescription fish-oil drug, while Pacira sues the FDA over the label for its pain drug, Exparel.
Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life
The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
US patent office declines to review two Ampyra patents; the FDA expands indication for Promacta; the Biosimilars Council argues against CMS proposal for biosimilar coding
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
Court blocks generic competition for Opana ER until 2023; lawmakers question Valeant drug price hikes; Roche's immuno-oncology drug meets primary endpoint in mid-stage trial
The FDA pushed back Opdivo's PDUFA date in light of new data; lawmakers argue about vet co-pays; Merck and MD Anderson Cancer Center to evaluate Keytruda in stomach and liver cancers
The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.
Spritam is a prescription epilepsy adjunct delivered orally.
The FDA discusses working with Google to identify unknown drug side effects; Tavenner named chief of insurer lobby group; drugmakers are starting to use cultural experts to better understand patient experience.
Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.
Last year's increase in CME support from manufacturers came after six straight years of declining budgets.
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs
The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.
While the FDA is not required to follow the panel's recommendation, the agency's final decision on Orkambi is crucial to Vertex's future.
Amarin sues FDA over off-label discussions; spike in HCV infections in US blamed on Endo opioid; Pfizer settles gambling, eating and sex addiction lawsuit
Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.
The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.
The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.
Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.
Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.
Two former Teva sales representatives claim the drugmaker used speaker programs to hide kickbacks for prescribing drugs Copaxone and Azilect.
America's Health Insurance Plans offered its opinion of the Actavis Namenda IR antitrust case, giving its support to New York Attorney General Eric Schneiderman.
The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.
Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.
FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."
FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.
President Barack Obama states in budget proposal that government should negotiate drug pricing; J&J's rare cancer drug's review is expedited; inhalable insulin hits pharmacy shelves.
President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.
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