Michael Swit

fda clinical study clinical trial warning letter anda clinical investigation park doctrine irb clinical site inspection gmp ftc enforcement nda compliance biosimilar generic drug clinical investigator 510(k) gcp 483 primary mode of action fdasia social media risk evaluation and mitigation strategy pmoa informed consent advertising sponsor interchangeability pma drug waxman-hatch 505(j) injunction aip seizure accelerated approval clinical trial registries medical device hatch-waxman office of generic drugs criminal prosecution consent decree request for designation fdaaa adverse events financial disclosure ind 505(b)(2) rems • patent certification unmet medical need rfd combination products lead center generic drug scandal bpcia internet cdrh bioequivalence pediatric research equity act 505(b)(1) exclusivity fast track vioxx office of criminal investigations hamburg application integrity policy device/biologic drug/device clinical trials results database clinicaltrials.gov facebook substantial equivalence brief statement best pharmaceuticals for children act bpca prea federal food drug and cosmetic act breakthrough therapy phase 4 study criminal liability drug/biologic cder surrogate endpoint ide procedures sops marketing twitter off-label intended use fair balance highly similar fdama user fees pediatric exclusivity office of combination products. ocp safety reimbursement substituion • naming • 30-month stay available therapy gain existing therapy clinically significant endpoints substantial improvement preliminary clinical evidence serious condition surrogate marker intermediate clinical endpoint meaningful therapeutic benefit severely debilitating life threatening subpart e responsible corporate officer collateral consequences medical devices first amendment caronia youtube guidance federal trade commission act patent extension otc drug monograph roche v bolar ogd biologics price competition and innovation act dietary supplement qui tam oci felony close out exclusion mdufma cber spoos 21 cfr 54 investigation new drug investigational device exemption tumblr false claims act interchangeable premarket notification nse sepp follow-on protein product biologic follow-on-biologic brief summary ivd smda orphan drug exclusivity therapeutic equivalence anda exclusivity drug price competition and patent term restoration premarket approval application paper nda pdufa elements to assure safe use etasu orphan drug designation planning paragraph iv rx-to-otc switch orange book rems subsequent entry protein product health claims misdemeanor prohibited acts section 704 disgorgement bla significant payments of other sorts hhs 21 cfr 50 valid scientific evidence pearson sorrell central hudson de novo 510k biosimilars untitled letter labeling investigational plan mobile medical applications digital health audit eir class iii seb fob marketing and advertising health care program exclusion competent and reliable scientific evidence amarin correcting ugc user generated content scientific exchange reminder ad in vitro diagnostic social media space limitation guidance social media marketing internet marketing reference product characterization anda suitability petition reference listed drug rld market exclusivity otc drug review dtc advertising unique device identifier udi refusal to permit inspection wyeth v levine drug safety protocol assistance office of orphan product development effectiveness pediatric center for medicare and medicaid services cms 505(b) 351(k) nutrient content claim structure and function claims crisis disclosure sec sarbanes-oxley rco recall combination product abney suthers ae 1572 investigational new drug ugc commercial speech crisis management indemnification se biogeneric generic ethics committee quality system ldt ruo promotional review committee carse misbranding superiority claims unapproved use clinical sponsored scientific and educational activities help seeking ad adequate provision 21 cfr 202.1 establishment inspection report unapproved 180-day exclusivity first to file generic drug enforcement act citizen petitions qualifying pathogens qidp qualified infectious disease product generating antibiotic incentives now gain act rare pediatric drug voucher food & drug administration safety & innovation act cmc grants henry waxman orphan drug who • usan • ndi notice dshea structure/function claim qualified health claim new dietary ingredient añada nada vitamins regulatory misbranded mccall caremark securities litigation deport caraco kv prosecution food drug & cosmetic act purdue frederick dotterweich oai vai nai import alert purdue pharma dia covered study good clinical practice world health organization icmje continuing review belmont report henry beecher declaration of helsinki nuremberg code gelsinger clinical research sae restricted device opdp sunshine act 502(n) 502(q) 502(r) clinical decision support software alivecor mhealth due diligence de novo cta ich quality clia laboratory developed test research use only adulteration orphan drug act facebook share widget tasigna major statement data integrity validation training records prc pom wonderful adequate substantiation ftca whistleblower adequate directions for use metatags 2253 minimizing risk overstating efficacy clinical practice guidelines good reprint practices unsolicited requests issea pharmacovigilance sameness nih internal audit transparency transfers of value tov teaching hospitals open payments health care provider hcp covered recipient covered product applicable manufacturer affordable care act pre-approval promotion software pds rta refuse to accept abbreviated 510(k) special 510(k) pre-submission indication predicate device not substantially equivalent pharmaceutical mou harmonization gatt tea rule otc drugs 1962 drug amendments nce-1 facility fee gdufa biosimilarity orrin hatch drug efficacy study implementation design waiver gail gillenwater eloxatin l e arthrotec 21 cfr 300.50 office of drug evaluation factorial study fixed dose combination drugs fda review substantial evidence complete response letter pre-bla meeting pre-nda meeting special protocol assessment margaret hamburg risk management civil penalties tax credits nord inn • biologics price competition and innovation act • 351(k) • 351(a) generic biologic subsequent entry biologic minor species major speciies abbreviated new animal drug application new animal drug application qualified health claims sec disclosure sox class i correction debarment ffdca market withdrawal clinical trial agreement material transfer agreement mta 3355 3354 bias record retention assent legally authorized representative lar international conference on harmonization ictrp contract ifc liability expedited review human subject protection common rule therapeutic misconception acrp global specific use general use 21 cfr 801.4 clearance promotion investigator mma naming qsr class ii 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 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 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 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 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 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 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 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 device modification 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 intellectual property paris convention treaty mutual recognition agreement mra memorandum of understanding iso international standards organization global harmonization task force ghtf congress 9001 13485 801 export import formularies settlements gratuity dingell 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 pharmaceutical ingredient 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 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 advice small-to-medium size enterprise 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 • bpcia • 351(a) • bla • generic biologic • fda • risk evaluation and mitigation strategy • interchangeability • sepp • seb • subsequent entry protein product • gain • existing therapy • clinically significant endpoints • substantial improvement • preliminary clinical evidence • serious condition • breakthrough therapy • fast track • phase 4 study • fdasia • surrogate marker • intermediate clinical endpoint • surrogate endpoint • meaningful therapeutic benefit • severely debilitating • life threatening • subpart e • accelerated approval • unmet medical need • available therapy • usan any given patient substituion functional food nutritional labeling nlea mineral nutrition ndi security raps affairs management adulterated nasdaq nyse 21 cfr 806 field alert recall classification stock recovery effectiveness checks health hazard assessment drugs suspend debar civil litigation charlie chang parenttoolbox mylan duty to investigate attorney fees non-compliance quality assurance program embargo u.s. attorney doj 301 inspections sponsor/investigator drug eluting stent biologic/drug 21 cfr 56 good clinical practices drug information association irbs msa master services agreement contract research organiation cro cda confidentiality minimize disqualification 21 cfr 312.70 slovenia emea eu clinical trial directive eu europe e6 international 3674 who acute myeloid leukemia aml gemtuzumab mylotarg central irb coast irb spitzer india indonésia china qualtiy hipaa investigation device exemption law liking links share widget pharmawall largo misbrand free speech advamed code general/specific pre-clearance wlf washington legal foundation scrutiny speech western states medical false claims ddmac clinical trials regulation exempt 202.1 1571 substitution gpha biologics outsourcing 207 513(f)(2) ema