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Nga pukapuka a te FDA me nga Aratohu Kaiwhakamahi

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.

Aki: whakauruhia te tau tauira katoa kua taia ki to tapanga FDA mo te whakataetae pai.

Tautoko FDA

Pae whaimana: https://www.fda.gov/
Tautoko whānui: https://www.fda.gov/about-fda/contact-fda
Waea tautoko: 1-888-463-6332 — Mon-Fri 8:00am - 4:30pm ET
imeera tautoko: webmail@oc.fda.gov
Puka whakapā: Whakapā tautoko kaihanga

Nga pukapuka a te FDA

Nga pukapuka hou mai i manuals+ kua whakaritea mo tenei waitohu.

He pukapuka a te Kaipupuri kirīmi Kanohi Kanohi FDA

Hanuere 24, 2025

Ngā Whakatakotoranga Kirimi Kanohi Māmā a te FDA mō ngā Tāne Momo Hua: HUMAN OTC DRUG TOPICAL Waehere Taonga (Pūtake): NDC:84522-526 Kai Whakakaha: Waikawa Salicylic 2% Kai Kore Whakakaha: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORPHENESIN, GLYCERIN,…

Ko te pukapuka a te Kaipupuri Kirīmi Ake Ake o te FDA

Hanuere 24, 2025

Ngā Whakatakotoranga Hua Kirimi Ārai-Pakeketanga FDA Ingoa Hua: Kirimi Ārai-Pakeketanga Momo Hua: Kirimi Kirikiri Matū Hohe: Niacinamide Kaha: 5 karamu i roto i te 100 karamu Ngā Matū Kore Hohe: Hinu Hīhi, Glycerin, Chlorphenesin, Palmitoyl…

FDA Meta Quest 3 Mixed Reality Headset 128 GB Aratohu Kaiwhakamahi

Hanuere 2, 2025

Paneoro Momo Whakaranu FDA Meta Quest 3 128 GB Aratohu Kaiwhakamahi Kaupapa Ko te kaupapa o tēnei tuhinga he tautoko i ngā kaiwhakamahi o te wheako Lilypad™ VR. E whakamārama ana i ngā whakaritenga hangarau, ngā tukanga…

FDA DTP-1 Marama i te Aratohu Kaiwhakamahi Ara Whanaketanga

Noema 27, 2024

Ngā Taunakitanga Aromatawai Pūrere me te Atanga Kaiwhakamahi i roto i te Hua Whakakotahitanga Rongoā-Pūrere PSGs Karthika Natarajan Hoa Kaimahi, DTP-1 | ORS | OGD CDER | US FDA Te Whakatairanga i te Wātea o te Hua Rongoā Whānui mā…

Arataki Kaiwhakamahi Rautaki Hangarau Korero FDA

Noema 13, 2024

Rautaki Hangarau Mōhiohio a te FDA mō ngā Tau Pūtea 2024 ki te 2027 Karere mai i te CIO He harikoa ki ahau te whakapuaki i tā mātou whakaputanga ā-tau o te Rautaki Hangarau Mōhiohio a te FDA mō te Tau Pūtea 2024…

FDA 6001.2 Whatunga o nga Tohutohu Tohutohu

Oketopa 28, 2024

Ngā Whakatakotoranga Whatunga Tohunga FDA 6001.2 Ingoa: Te Pokapū Arotake me te Rangahau Rongoā (CDER) Whatunga Tohunga (NoE) Tuhinga: MAPP 6001.2 Arotake 2 Te Rā Whai Mana: 10/23/15; 10/8/21; 2/1/24 Ngā Mōhiotanga Hua…

He Aratohu Kaiwhakamahi Korero mo te rongoa rongoa a te FDA

Oketopa 23, 2024

Ngā Mōhiohio Rongoā Tūroro Ngā Whakatakotoranga Mōhiohio Hua: Ingoa Hua: Ngā Mōhiohio Rongoā Tūroro (PMI) Momo: Aratohu Rongoā kua whakaaetia e te FDA Rokiroki: Putunga pokapū ipurangi e whakahaerehia ana e te FDA Wātea: Wātea noa ki te marea Hua…

FDA CDER Electronic Record Keeping Systems Manual a te Kaipupuri

Oketopa 19, 2024

Ngā Pūnaha Pupuri Rekoata Hiko a te FDA CDER TE WHAKATAUNGA Ka tuhia e tēnei MAPP ngā Pūnaha Pupuri Rekoata Hiko (ERKS) a te CDER, ā, ka whakamāramahia ngā kaupapa here me ngā tikanga whakahaere mōna. Kei roto i tēnei ko ngā mea e whai ake nei: Te Whakamārama…

FDA MAPP 6702.1 Review o te Aromātai Morearea me te Rautaki Whakaitihia te pukapuka a te Kaipupuri

Oketopa 19, 2024

FDA MAPP 6702.1 Review o ngā Whakatakotoranga Rautaki Aromatawai me te Whakaiti i te Mōrearea Ingoa Hua: Pukapuka ā-ringa mō ngā Kaupapa Here me ngā Tukanga Te Pokapū mō te Aromatawai me te Rangahau Rongoā (MAPP 6702.1) Tari Taketake: Tari o…

FDA CDER NextGen Portal Aratohu Kaiwhakamahi

Oketopa 19, 2024

Ngā Whakatakotoranga o te Tomokanga NextGen CDER FDA: Ingoa Hua: Tomokanga NextGen CDER Ngā Pūtirotiro e Tautokona ana: Internet Explorer, Google Chrome, Mozilla Firefox Āhuatanga Haumarutanga: Whakamotuhēhēnga Maha-Tauwehe (MFA) mā te īmēra Ngā Tohutohu Whakamahinga Hua Te tono i tētahi…

Pukapuka Kaiwhakamahi GUDID: Me pēhea te Wewete me te Whakatika i ngā Rekoata Pūrere i roto i te Pūtake Raraunga FDA

Pukapuka Kaiwhakamahi

He pukapuka ā-ringa tēnei e whakarato ana i ngā tohutohu mō te wetewete me te whakatika i ngā tuhinga o te pūrere i roto i te Pūtake Raraunga Tautuhi Pūrere Ahurei o te Ao (GUDID) a te FDA, e kapi ana i te tukanga wetewete, ngā tikanga whakatika, me ngā whakaaro nui…

Aratohu Kaiwhakamahi Rēhita Whare Kai FDA: Ngā Āheinga Tāpiri

Aratohu Kaiwhakamahi

He aratohu kaiwhakamahi whānui mai i te US Food & Drug Administration (FDA) e whakaatu ana i ngā āheinga tāpiri i roto i te pūnaha Rehitatanga Whare Kai (FFR), tae atu ki te whakahaere i ngā rēhitatanga, ngā whakakorenga, me te rapu mōhiohio mō ngā whare.

Aratohu Tāpiri FDA ACE: Aratohu Tohutoro Tere Ahumahi v2.5.3

Arataki

He aratohu tere whānui mō ngā kaikawemai me filengā mahi mō te tuku kōrero ki te FDA mō ngā hua kua whakahaeretia e uru ana ki te Hononga o Amerika mā te pūnaha Taiao Arumoni Aunoa (ACE), e kapi ana i…

Aratohu ā-ringa mō ngā kaimahi o te FDA 1121.934: Ngā Whakahaere me ngā Mahi o te Taiwhanga Kai me te Whāngai ki te Tai Rāwhiti

Pukapuka ā-ringa mō ngā kaimahi

He Aratohu Whaimana mō ngā Kaimahi FDA 1121.934 e whakaatu ana i te hanganga whakahaere me ngā kawenga mahi o te Taiwhanga Kai me te Whāngai o Te Tai Rāwhiti (DCIFCD) me ōna peka, tae atu ki te Peka Matū 1, te Peka Matū…

Te Tukatuka Ā-Aseptic o ngā Hua Koiora: Ngā Take Ture o Nāianei me ngā Wero Hanga

Tuhinga Aratohu

He aratohu mō ngā take ture o nāianei me ngā ngoikoretanga noa i roto i te tukatuka ā-pūmua o ngā hua koiora, e kapi ana i ngā ture, ngā whakaritenga, te ihirangi BLA, te whakamana tukanga, te tātari whakahoromata, te rokiroki i muri i te hanganga/whakaranutanga, me te pono o te katinga o te ipu. I whakaaturia…

Pukapuka Tātari Huakita Upoko 23: Ngā Tikanga mō ngā Whakapaipai - FDA

ā-ringa

He aratohu whānui e whakaatu ana i ngā tikanga whakamātautau moroiti mō ngā hua whakapaipai, tae atu kiampte whakarite, te tatau, te tautuhi i ngā moroiti, me te whakamātautau i te whai huatanga o ngā mea tiaki, e ai ki tā te US Food & Drug Administration (FDA).

FDA ESG NextGen AS2 Aratohu mo nga Kaiwhakamahi Ahumahi - Putanga 2.0

Arataki

He aratohu whai mana mo nga kaiwhakamahi ahumahi mo te tuku raraunga ma te AS2 ki te punaha NextGen Electronic Submission Gateway (ESG) a te FDA. Ka kapi i te whirihoranga, te tukanga tuku, me te rapurongoā.

Mahinga ACE mo koe: Kawemai i te Aratohu Hua Kua Whakaritea e te FDA

Arataki

He aratohu whānui mai i te US Food and Drug Administration (FDA) e whakamārama ana me pēhea te whakamahi tika i te Automated Commercial Environment (ACE) mō te kawemai i ngā hua e whakahaeretia ana e te FDA, e kapi ana i ngā tukanga matua, ngā take noa,…

Ngā Tukunga ANDA: Aratohu Ihirangi me te Hōputu mō te Ahumahi

Arataki

He aratohu a te US FDA mō te ahumahi mō ngā Tono Rongoā Hou Whakarāpopoto (ANDA), e whakaatu ana i ngā whakaritenga ihirangi me te whakatakotoranga mā te whakamahi i te hanganga Tuhinga Hangarau Noa (CTD) mō ngā tuku hua rongoā.

He Aratohu FDA mo nga Tuhinga, Mana Huri, me te Whakahaere Rekoata

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He aratohu whānui mai i te US Food and Drug Administration (FDA) mō te whakahaere tuhinga, te whakahaere huringa, Ngā Rekoata Matua Pūrere (DMR), Ngā Rekoata Hītori Pūrere (DHR), me Ngā Rekoata Pūnaha Kounga (QSR) e ai ki…

Te maarama ki te punaha Kounga Rongoa (PQS) mo nga Tirotiro FDA

Arataki

He mutuview o te Pūnaha Kounga Rongoā (PQS) i tukuna e te FDA, e arotahi ana ki ngā CGMP, ICH Q10, me ngā rautaki tirotiro a te FDA. Akohia ngā tumanakohanga kounga me ngā whakaritenga ture mō ngā rongoā…

Te Kaupapa Tautukunga a te FDA 7356.002: Nga Tirotiro Hanganga Rongoa

Kaupapa Whakatutukitanga

Kei roto i tenei tuhinga nga korero a te US Food and Drug Administration's Compliance Programme 7356.002, e whakarato ana i nga aratohu mo nga tirotirohanga hanga tarukino, te whakapumautanga o te kounga, nga whakaritenga CGMP, me te tirotiro ture mo nga hua rongoa.