scholarly journals FDA Warning Letter: Avoidance and Advice

2011 ◽  
Vol 14 (3-4) ◽  
pp. 76-79
Author(s):  
T. Winchell
Keyword(s):  
1966 ◽  
Vol 4 (4) ◽  
pp. 13-13

Last month the US Food and Drug Administration required American manufacturers of long-acting sulphonamides (sulphamethoxypyridazine, Lederkyn - Lederle and Midicel - PD; sulphadimethoxine - Madribon - Roche) to warn prescribers that in rare cases the Stevens-Johnson syndrome may develop as a severe and sometimes fatal side effect. This syndrome is a type of erythema multiforme in which large blisters appear on the skin and especially on the mucous membranes. The manufacturers were also to advise doctors ‘to consider prescribing short-acting sulphonamides first because they are effective for most of the same conditions’. The three drug firms concerned accordingly sent a joint warning letter to all doctors, pointing out that the Stevens-Johnson syndrome is a serious complication with a mortality rate of about 25%. So far 116 cases of this syndrome have been reported in association with the use of long-acting sulphonamides, most of them in the United States. Almost two thirds of the patients were children.


2018 ◽  
Vol 1 (1) ◽  
pp. 26
Author(s):  
Fransisca Kusuma Aryani ◽  
Gunawan Djajaputra

The process of granting credit with the guarantee of Mortgage Rights experienced many obstacles, one of which is the cancellation of credit agreement due to a lawsuit from a third party. Examples of problems that will researchers take is a case between PT PNM as creditor and Erlinawati as a debtor. Erlinawati applied for credit to PT PNM and pledged SHM No. 1716 without her husband's agreement, Bagus Satriya. As time went by, Erlinawati could not fulfill its obligations as stipulated in the credit agreement, and then PT PNM sent a warning letter to Erlinawati. Good people who know the land and buildings of his property are used as a direct guarantee to file a lawsuit to the Blora District Court. The Blora District Court ruled that credit agreements and Deed of Mortgage Rights (APHT) are invalid and null and void. So far the legal protection for debtors who have sued from the other party on the guarantee given by the creditor has not been regulated specially in the legislation. The law only regulates bad debts and debt repayment through the execution process stipulated in the Law on Banking and Insurance Rights Act. Legal protection that creditor can use when obtaining a lawsuit from a third party is by using the general guarantees provided for in Articles 1131 and 1132 of the Civil Code.


Author(s):  
Mote NN ◽  

The main objective of selecting this topic because of many pharmaceutical companies receives the 483 observations/ warning letters from the USFDA. The reason of most of 483 observations/warning letters was inadequate investigation of Laboratory Non-Conformances. It includes Out of specification/Out of trend investigation. The inadequate investigation because of unawareness of regulatory guidance requirements while performing the investigation. If any company receives 483 observations/warning letter it will impact on company reputation in the market and also impact on company revenue. So as to avoid this we should know the some basic concept while performing the out of specification/Out of trend investigation.


2014 ◽  
Vol 44 (2) ◽  
pp. 9-11
Author(s):  
William A. Hyman
Keyword(s):  

2016 ◽  
Vol 11 ◽  
pp. 39-43 ◽  
Author(s):  
Gamal Al-Saied ◽  
Talal Al-Malki ◽  
Mohamed Ayoub ◽  
Tharwat Hussain ◽  
Riyad Thabet ◽  
...  
Keyword(s):  

2021 ◽  
Vol 1 (1) ◽  
pp. 69
Author(s):  
Lita Paromita Siregar

<em>In accordance with Law Number 5 of 1999 concerning Competition Law, every corporate action that causes monopoly must be notified to the Business Competition Supervisory Commission (KPPU) in less than 30 (thirty) days. However, not all entrepreneurs are aware of this provision. As consequence of the delay, entrepreneurs are potentially subject to wide range of sanctions starting from warning letter, fines, to the worst scenario which is the cancellation of the corporate action. Law Number 40 of 2007 concerning Company Law governs that all corporate action including mergers, acquisition and consolidation should be drawn in form of notarial deed and the Notary has an access to report such action to the Minister of Law and Human Rights if necessary. While the entrepreneurs appear before the Notary to make merger, acquisition or consolidation deed, the Notary may advise the entrepreneurs to notify KPPU if such merger is potentially fulfill certain condition under Law No.5 of 1999. However, Notary must also be aware that his role is limited by his responsibility to keep private information disclosed by the party before him. In connection with those conditions, this research provides elaboration on how Notary should take a role in merger action and his limitation in it.</em><p><strong>BAHASA INDONESIA ABSTRACT: </strong>Undang-Undang Nomor 5 Tahun 1999 tentang Persaingan Usaha mengatur bahwa dalam hal terjadi aksi korporasi yang menyebabkan monopoli, maka pelaku usaha wajib untuk memberikan pemberitahuan atas peristiwa tersebut dalam jangka waktu 30 (tiga puluh) hari kepada Komisi Pengawas Persaingan Usaha (KPPU). Akan tetapi, tidak semua pelaku usaha memahami ketentuan ini. Oleh sebab itu, pada beberapa kasus pelaku usaha dikenai sanksi yang bervariasi, mulai dari surat teguran, denda dalam jumlah besar, hingga pembatalan<em> </em>aksi korporasi tersebut. Sehubungan dengan kondisi ini, Undang-Undang Nomor 40 Tahun 2007 tentang Perseroan Terbatas mengatur bahwa setiap aksi korporasi yang meliputi penggabungan, peleburan dan pengambilalihan akuisisi harus dituangkan persetujuannya oleh para pemegang saham dalam suatu akta notariil dan dilaporkan oleh Notaris kepada Menteri Hukum dan Hak Asasi Manusia apabila diperlukan. Sehubungan dengan pengaturan tersebut, maka setiap kali para pelaku usaha hadir di hadapan Notaris untuk membuat akta<em> </em>atas aksi korporasi, Notaris dapat mengambil peran untuk mencegah terjadinya keterlambatan pemberitahuan tersebut melalui pemberian penyuluhan kepada para penghadap. Akan tetapi, Notaris juga harus tahu bahwa perannya tersebut juga terbatas pada kewajibannya untuk menjaga informasi dari para pihak yang menghadapnya. Berkaitan dengan hal tersebut, penelitian ini mencoba untuk mengelaborasi peran Notaris dalam mencegah keterlambatan pemberitahuan tersebut sejauh mana peran yang dapat diambil Notaris sehubungan dengan hal tersebut.</p>


2018 ◽  
Vol 3 (1) ◽  
pp. 23
Author(s):  
Fika Wahyuningtyas ◽  
Alia Ariesanti

Tax collection by using a letter of reprimand and forced letter is an effort to increase the effectiveness of tax revenue that purpose as the country's development. This research method aims to determine the level of effectiveness of the tax collection and forced letter warning letter. The research method uses descriptive method of analysis, methods based on existing data, and then draw conclusions. This study uses secondary limit the period 2011-2012. Analysis using ratio analysis to calculate the effectiveness of tax collection by using related variables that include the amount of the tax billing plan and the amount of tax revenue. The results showed that the effectiveness of tax collection with a letter of reprimand and a letter run ineffectively enforced, so expect authorize agencies in collecting tax debts can be optimized, see realize taxes are still very small


2021 ◽  
Vol 3 (2) ◽  
pp. 63-67
Author(s):  
Syarief Rahman Tasman ◽  
Zulkifli Makkawawu ◽  
Yulia A. Hasan

Tujuan Penelitian ini adalah untuk mengetahui cara penyelesaian kredit bermasalah di Bank BNI 46 Cabang Polewali Mandar. Metode yang digunakan untuk penelitian ini adalah metode deskriptif yaitu dengan menguraikan data secara sistematis dari fakta-fakta yang didapat kemudian dihubungkan dengan prosedur penyelesaian kredit bermasalah pada Bank BNI 46 Cabang Polewali Mandar. Terjadinya Kredit bermasalah di Bank BNI 46 disebabkan oleh faktor intern yaitu pejabat kredit mudah dipengaruhi atau dipaksa oleh calon nasabah, kurangnya pemahaman terhadap kebutuhan keuangan yang sebenarnya dari calon nasabah dan manfaat kredit yang diberikan seperti kredit modal kerja digunakan untuk komsumtif, kurangnya pengecekan latar belakang calon nasabah dan juga disebabkan oleh faktor ektern yaitu karena merosotnya perekonomian debitur, terjadinya PHK mendadak ditempat kerja debitur, penurunan omset usaha debitur, dan Upaya penyelesaian Kredit bermasalah yang disebabkan oleh Faktor Intern dilakukan dengan peringatan tertulis dalam bentuk Surat Peringatan (SP), mutasi dan penurunan jabatan, serta upaya penyelesaian Kredit bermasalah yang disebabkan oleh faktor ekstern dilakukan dengan mengirim Surat Peringatan SP I sampai SP 3 melakukan penangihan kepada pihak yang ikut serta menandatangani perjanjian kredit dan terakhir melakukan penarikan dan pelelangan agunan. The purpose of this study was to determine what to find out how to solve problem loans at Bank BNI 46 Polewali Mandar Branch. The data analysis method for this research is descriptive method, namely by describing the data systematically from the facts which can then be linked to the procedure for solving problem loans at Bank BNI 46 Polewali Mandar Branch. The occurrence of non-performing loans at Bank BNI 46 is caused by internal factors, namely credit officials who are easily influenced or forced by prospective customers, a lack of understanding of the actual financial needs of the prospective customer and the benefits of loans such as working capital loans used for commercial use, lack of background checks on candidates customers and also caused by external factors, namely due to the decline in the debtor's economy, sudden layoffs at the debtor's workplace, a decrease in the debtor's business onset, and efforts to resolve problem loans caused by Internal Factors are carried out with written warnings in the form of Warning Letters (SP), mutations and decreases position, as well as efforts to resolve non-performing loans caused by external factors are carried out by sending a warning letter from SP I to SP 3 for invoicing the parties participating in signing the credit agreement and finally making a withdrawal and auction of collateral.


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