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fda clinical study clinical trial warning letter anda clinical investigation park doctrine irb clinical site gmp inspection nda compliance enforcement biosimilar ftc clinical investigator 510(k) generic drug gcp 483 primary mode of action fdasia social media pma informed consent interchangeability risk evaluation and mitigation strategy sponsor advertising pmoa accelerated approval waxman-hatch seizure injunction medical device 505(j) aip drug clinical trial registries ind fdaaa financial disclosure adverse events consent decree hatch-waxman request for designation office of generic drugs criminal prosecution generic drug scandal rems 鈥� bioequivalence unmet medical need lead center combination products 505(b)(2) rfd cdrh patent certification bpcia internet clinical trials results database hamburg fast track 505(b)(1) clinicaltrials.gov facebook substantial equivalence office of criminal investigations exclusivity drug/device pediatric research equity act device/biologic application integrity policy vioxx fair balance cder off-label intended use federal food drug and cosmetic act fdama brief statement criminal liability ide procedures sops drug/biologic best pharmaceuticals for children act bpca highly similar prea surrogate endpoint twitter breakthrough therapy phase 4 study marketing user fees responsible corporate officer collateral consequences 30-month stay safety medical devices ocp reimbursement office of combination products. caronia first amendment naming 鈥� pediatric exclusivity substituion 鈥� subpart e surrogate marker serious condition available therapy gain guidance intermediate clinical endpoint existing therapy meaningful therapeutic benefit clinically significant endpoints substantial improvement preliminary clinical evidence severely debilitating youtube life threatening biologics price competition and innovation act interchangeable 21 cfr 54 spoos oci exclusion premarket notification federal trade commission act investigation new drug close out investigational device exemption follow-on-biologic otc drug monograph dietary supplement roche v bolar patent extension tumblr cber biologic ogd follow-on protein product qui tam mdufma false claims act sepp felony nse audit prohibited acts subsequent entry protein product rems digital health pdufa orphan drug exclusivity therapeutic equivalence significant payments of other sorts anda exclusivity drug price competition and patent term restoration fob health claims hhs seb bla disgorgement class iii premarket approval application smda 21 cfr 50 paper nda section 704 ivd eir pearson planning sorrell central hudson brief summary misdemeanor valid scientific evidence untitled letter orphan drug designation labeling paragraph iv rx-to-otc switch de novo 510k biosimilars orange book mobile medical applications investigational plan elements to assure safe use etasu ethics committee amarin anda suitability petition suthers abney rco combination product commercial speech correcting ugc refusal to permit inspection udi unique device identifier recall marketing and advertising biogeneric reference product disclosure scientific exchange sec reference listed drug structure and function claims dtc advertising sarbanes-oxley rld competent and reliable scientific evidence market exclusivity generic 505(b) characterization otc drug review user generated content pediatric in vitro diagnostic nutrient content claim effectiveness ae crisis 1572 indemnification investigational new drug internet marketing social media marketing office of orphan product development social media space limitation guidance 351(k) crisis management protocol assistance ugc health care program exclusion wyeth v levine drug safety cms reminder ad center for medicare and medicaid services se deport food & drug administration safety & innovation act structure/function claim dotterweich henry waxman dshea generic drug enforcement act caraco usan 鈥� first to file ndi notice 180-day exclusivity grants purdue frederick food drug & cosmetic act vitamins prosecution who 鈥� import alert dia purdue pharma cmc qualified health claim vai new dietary ingredient qualifying pathogens oai regulatory qidp securities litigation qualified infectious disease product 补帽补诲补 nada generating antibiotic incentives now misbranded gain act orphan drug nai citizen petitions caremark mccall rare pediatric drug voucher kv covered study clinical sponsored scientific and educational activities help seeking ad unapproved quality system de novo adequate provision promotional review committee 21 cfr 202.1 good clinical practice mhealth continuing review alivecor world health organization clinical decision support software 502(n) 502(q) 502(r) restricted device due diligence establishment inspection report ruo ldt gelsinger clinical research carse sae misbranding ich cta sunshine act superiority claims opdp nuremberg code icmje belmont report henry beecher declaration of helsinki unapproved use fda review substantial evidence major statement internal audit margaret hamburg acrp complete response letter global mma health care provider open payments transparency affordable care act applicable manufacturer ffdca transfers of value tov special protocol assessment teaching hospitals covered product pre-nda meeting covered recipient pre-bla meeting hcp unsolicited requests biologics price competition and innovation act 鈥� class i 351(k) 鈥� correction good reprint practices promotion clinical practice guidelines debarment overstating efficacy minimizing risk 2253 metatags adequate directions for use whistleblower ftca adequate substantiation pom wonderful risk management investigator data integrity civil penalties nih tax credits validation training specific use nord general use sameness pharmacovigilance 21 cfr 801.4 clearance records issea inn 鈥� prc otc drugs gdufa biosimilarity tea rule lar minor species adulteration international conference on harmonization gatt orphan drug act harmonization orrin hatch class ii drug efficacy study implementation design ictrp mou waiver pharmaceutical contract bias 3354 3355 mta material transfer agreement quality qualified health claims clia laboratory developed test nce-1 clinical trial agreement new animal drug application 1962 drug amendments research use only abbreviated new animal drug application record retention major speciies assent facility fee legally authorized representative ifc 21 cfr 300.50 predicate device indication pre-submission special 510(k) abbreviated 510(k) refuse to accept arthrotec rta facebook share widget tasigna e market withdrawal pds software human subject protection sox l common rule pre-approval promotion gail gillenwater eloxatin sec disclosure qsr therapeutic misconception subsequent entry biologic naming liability fixed dose combination drugs generic biologic not substantially equivalent factorial study 351(a) office of drug evaluation expedited review debar suspend nasdaq affairs drugs raps ema civil litigation charlie chang outsourcing 202.1 management biologics nyse gpha adulterated 207 1571 substitution 513(f)(2) 21 cfr 806 field alert recall classification stock recovery effectiveness checks health hazard assessment europe e6 international 3674 who acute myeloid leukemia aml biologic/drug gemtuzumab mylotarg drug eluting stent central irb coast irb spitzer india 颈苍诲辞苍茅蝉颈补 china minimize disqualification confidentiality cda cro contract research organiation master services agreement 21 cfr 312.70 msa irbs drug information association good clinical practices 21 cfr 56 slovenia emea eu clinical trial directive eu qualtiy quality assurance program general/specific pre-clearance wlf washington legal foundation scrutiny non-compliance speech western states medical attorney fees false claims duty to investigate ddmac clinical trials regulation exempt mylan hipaa investigation device exemption law sponsor/investigator inspections 301 doj liking links u.s. attorney share widget pharmawall largo embargo misbrand free speech advamed code health seeking ad direct-to-consumer balance risk pre-de novo submission meeting apotex ranbaxy genzyme mensing changes being effected cbe state substitution laws rp food cdc kefauver-harris amendments 1938 elixir sulfanilmide the jungle upton sinclair forum chat rooms blogs space limitation tweet unsubstantiated benefit/risk nccn medical reference text scientific journal medical journal section 401 independence clinical support texts reprints industry pre-dissemination review television tv ad office of new animal drug evaluation major/minor uses major/minor species animal drug priority review pre-approval inspection supplement general/specific use 21 cfr 812.7 non-inferiority conformity standard significant risk device device classification 201(h) safe medical devices act commissioner center for devices & radiological health cardiac lunch cardiovascular device technological characterization pure food & drug act virus toxin law biologics control act 1902 harvey wiley new drug application cpg 130.300 aegerion blinding fpla animal medicinal drug use clarification act amduca medicated feed adufa minor use/minor species mums investigational new animal drug inad 201(v) onade rebecca k. wood scott gottlieb pre-rfd depomed rare disease day global genes national organization for rare disorders novel drug 200000 incidence prevalence #orphandrugact #raredisease #orphandrug carve out 520(o) multiple function 21st century cures act cds patient decision support software mlr cfl facebook marketing omitting risk information journal ads disseminating scientific information consumer brief summary biomedical startup aseptic processing manufacturing fresenius akorn principal investigator good manufacturing practice barr case establishment registration samples 482 drug listing predissemination review civil money penalties 505b risk guidance fopp sebi salami slicing clinical superiority bsufa conflicts of interest institutional review board third party posts social media monitoring social media strategy national advertising division nad endorsements deception relator metadata subject nomenclature pv w.h.o. usp u.s. adopted name council proper name core name suffix brand name non-proprietary name corporate culture audits compliance officer google ads space limited ad udell friedman oig continuing medical education device modification sme rtf refuse to file advisory committee spa eop end of phase 2 toxicology preclinical lucentis macugen josh sharfstein ophthalmic medication guides post-approval studies abbey meyers marlene haffner rare disorder rare disease any given patient 鈥� products liability phenergan demerol preemption fdli perez v nidek fraud code of conduct ethics biologics licensing application california institute for regenerative medicine cirm california stem cell research and cures act proposition 71 stem cell chemistry manufacturing and controls sawp scientific advice working party scientific 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settlements gratuity dingell pre-de novo submission modifications changes office of device evaluation ode scp standing committee on the law of patents first to invent european patent convention epc world trade organization wto world intellectual property organization wipo patent cooperation treaty pct nafta trade-related aspects of intellectual property trips uruguay rounds api pastor prior approval supplement dmf generic drug user fee act ftf patent restoration humanitarian device exemption hde deferral pediatric assessment pediatric rule dan troy andrew von eschenbach lester crawford food & drug administration amendments act of 2007 private right of action failure to warn impossibility preemption implied conflict preemption desi essential to approval 3-year exclusivity nce new chemical entity reformulation brand vs. generic omnitrope qbr question based review food effect in vitro in vivo pharmaceutical equivalents bioavailability rtr refuse-to-receive crl regulatory science active 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