https://t.co/CYlWMukB6K "A 2006 report states that only 10% to 15% of FDA device submissions contain any clinical data at all (30).
@CompassDrifter @ConnorJD_ @writebrainedny @jonivy @NoLieWithBTC Also, re European regulatory oversight... Note that the U.S. market is six times larger in total dollars than Germany (the largest EU spender by far). EU member approvals are still decentrali
@Black300Joe @gabrielepx Che poi i processi di autorizzazione tra FDA e EMA non sono così diversi. https://t.co/KmO5PGdoos
@markoftec @Imonlyslightly @PhilipWatson_ @trishgreenhalgh Pharma is very well regulated in the US & Europe more so than cars, home equipment & food ingested. So these self reports without a control group & verification are close to useless. h
A 2016 comparison of the two systems notes the FDA was formed in essence as a consumer protection agency, while the purpose of the European Medicine Agency (EMA) is instead to harmonize interstate commercial interests while preserving national autonomy. ht
@fragileuk1 @slomka_robert @PaulLeMay16 @DarrenEuronews I'm glad you're still here, mate. I stand corrected that the UK could not authorise drug approvals independently. However, it appears that it is / was only for those drugs that "fall outside of those
@BlakeClint @torfsrik "the FDA is sometimes seen as overplaying safety concerns at the cost of commercial enterprise, whereas the European systems are sometimes characterized as being primarily concerned with preserving commercial interests to the detrimen
@himbonomics @conor64 @SipOfKoKo Also, not about drugs but medical devices, and this is interesting https://t.co/rmymUEwzYq https://t.co/VskGicfvNN
RT @gallir: Finalmente la EMA aprobó con semanas de retraso lo que era obvio. El teatro. Nota: la FDA es centralizada, con muchos recursos…
Finalmente la EMA aprobó con semanas de retraso lo que era obvio. El teatro. Nota: la FDA es centralizada, con muchos recursos, suele ser más lenta que EMA (le critican por ello) y trata los datos no publicados con más transparencia que la EMA https://t.c
@My3Alexandra @BetoGuero @Acosta "All of the drugs that were approved by both the FDA and EMA were available sooner to patients in the United States, in part because of consistently shorter review times at the FDA." https://t.co/eE2Wt7nABE
Drugs and Devices: Comparison of European and U.S. Approval Processes [Clearance] https://t.co/p4mQ4avg7h
@MaraWilson made me feel better! https://t.co/ygSCYP68Dz https://t.co/fTeNPsU0hj
@dougbootle @afneil Approval of a drug can go through the EMA OR a national body. The advantage of going through the EMA is automatic approval in all EU states. But that doesn't mean its standards are any higher than those of individual EU member states's
@Omz2468 @afneil The EMA is there primarily to coordinate the individual regulatory authorities for commercial purposes. Have a read: https://t.co/4gagd9gQvX
@afneil Nancy Pelosi may have a point: Drugs and Devices: Comparison of European and U.S. Approval Processes https://t.co/nSmi2zwhoH
@Noahpinion This is not true, in general. Here's a reference https://t.co/NOJBitZKNd.
@parkerrm39 New drugs reach patients faster in the US than in Europe, at least according to this: https://t.co/El2Vdtfip9 That said, accusing FDA's safety procedures to be yet another "deep state" conspiracy (obviously without any evidence) is beyond irres
Drugs and Devices: Comparison of European and U.S. Approval Processes https://t.co/KPZSyj9zCv
@DaddyLegs Interesting https://t.co/OBPklybI87
@DavidKennedy80 @US_FDA @EMA_News Hi @DavidKennedy80; it depends on a number of factors. This publication on the US and EU approval processes may help answer your question: https://t.co/yshvd7Rfnx
@spectator In fact the EMA takes longer than the FDA on average - 366 days compared with 303 days. You don't have to believe me but see https://t.co/r0zqIt5ph2 The Spectator is really best not relied upon for objectivity and accuracy (after all Johnson use
@AfflictedMed @lawmaster @balajis This isn’t actually true. More drugs are approved in the US, and FDA approval is substantially quicker compared to EMA approval. Canada is even stricter. https://t.co/HTWK3S7wJc
@Ricardo57426966 @HaiseSpirits @LuisedHdez @sdbruin97 @fl4nfl4n @bernieornada @Sachmozi @jcarterb13 @blessedBOMBsheL @BernieSanders Show me your source saying more people go to Cuba than the US because Mick Jagger sure didn't stay in the EU or go to Cuba t
https://t.co/mXsp5vD9Oe 💊 Drugs and Devices: Comparison of European and U.S. Approval Processes by Gail A. Van Norman https://t.co/mG7zp00eFR
RT @Tanzeel_Akhtar: Further reading for followers ... "Drugs and Devices: Comparison of European and U.S. Approval Processes" https://t.co…
RT @Tanzeel_Akhtar: Further reading for followers ... "Drugs and Devices: Comparison of European and U.S. Approval Processes" https://t.co…
Further reading for followers ... "Drugs and Devices: Comparison of European and U.S. Approval Processes" https://t.co/amxMc0rkfS
@prrrjoy @DrJokrrf @LynnS253 @SenatorRomney @SenateGOP Analysis indicates that drugs actually reach the public more quickly in the United States than Europe. Pharma is investing in more research in EU than US. Pharma needs to be honest & tax payer ne
This report on Medical devices approved in the EU... and then a Eucomed statment that corrects only sematics. Loopholes in healthcare are scary. https://t.co/gg1ZrAvATq https://t.co/cdcw20Tih0
@Crypto_Naruto @AwesomeSaucer9 @GreyWyvern @mnrothbard ... the FDA is sometimes seen as overplaying safety concerns at the cost of commercial enterprise, whereas the European systems are characterized as being primarily concerned with preserving commercial
@statsepi After watching this, was curious to see how it works in Europe. According to this, it's just as bad as in the US. E.g. easy approval for fictitious metal-on-metal hip implant deliberately specified in the application to be toxic: https://t.co/oP
@mgtmccartney @MattHancock Does the babylon app have CE mark? If not, isn't it down to NHSE not to accept use of device unless it meets EU regs? https://t.co/hFQuGeePWa (Sorry if this seems naive, am just lay person) https://t.co/afdpGMuvaC
@RedOwlDr 2/3rds drugs in US faster approval than EU (median 90 dys sooner; 6mo for oncology!) https://t.co/7PZkJIZs6J = more, faster, prob better