Drug Shortage Report for ALTACE HCT. Life Sciences Drug establishments will need to amend their standard operating procedures and inventory systems to aggregate annual production amounts for commercial distribution per listed product for reporting to FDA.

Life Sciences Last updated on 2020-05-13 History. Drug Shortage Report for ALTACE HCT. Manufacturers will need to amend their SOPs to ensure alignment with expanded and new FDA authorities on reporting permanent discontinuations or interruptions leading to “meaningful disruptions” in supply. For device manufacturers, initial assessments may be required to determine whether any of a company’s products fall under the new definition of a critical device. Last updated on 2020-08-13 History. FDA has been able to collect information on drug shortages and take steps to help prevent or mitigate such shortages under authorities set forth in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). FDA FDA The drug shortage reporting requirements now include additional disclosure of the source and alternative sources of API, and API manufacturers should prepare for additional communication and engagement with their supply chain partners necessary to facilitate such reporting.These provisions of the CARES Act represent important updates to FDA’s authorities to manage medical product shortages, and we will continue to monitor FDA communication and guidance intended to help manufacturers fulfill these new obligations. However, FDA had not, until now, had equivalent authority with regard to shortages of critical devices.

Contact Goodwin FDA team members Last updated on 2020-05-13 History. Webinar Recording: Putting the U.S. CARES Act into Context Market Status: MARKETED: Active Ingredient(s) HYDROCHLOROTHIAZIDE RAMIPRIL: Strength(s) 25.0MG 5.0MG: Dosage form(s) …
Additionally, the Act enhances FDA’s existing authority with respect to drug shortage measures. Market Status: MARKETED: Active Ingredient(s) RAMIPRIL HYDROCHLOROTHIAZIDE: Strength(s) 2.5MG 12.5MG: Dosage form(s) … Last updated on 2020-08-13 History. FDA Drug Shortage Report for ALTACE HCT. Drug Shortage Report for ALTACE. Market Status: MARKETED: Active Ingredient(s) HYDROCHLOROTHIAZIDE RAMIPRIL: Strength(s) 12.5MG 5MG: Dosage form(s) TABLET: … Business and Individual Income Tax Provisions of the CARES Act Below, we have highlighted the key provisions in these areas under the new law:Although the CARES Act is a response to a still-developing pandemic, the updated and expanded FDA authorities under the Act will result in lasting obligations for drug and device manufacturers and suppliers, even after the COVID-19 pandemic is under control. Life Sciences Market Status: MARKETED: Active Ingredient(s) HYDROCHLOROTHIAZIDE RAMIPRIL: Strength(s) 25.0MG 5.0MG: Dosage form(s) … Report ID: 104130: Drug Identification Number: 02221829: Brand name: ALTACE: Common or Proper name: ALTACE: Company Name : VALEANT CANADA LP/VALEANT CANADA S.E.C.

Drug manufacturers with critical drug products must now develop, maintain, and implement risk management plans that identify and evaluate the risks to the supply of such drugs for each establishment where the drug or API is made. Last updated on 2020-07-29 History. While the statute allows the Secretary to exempt certain biological products from this reporting if unnecessary to protect the public health, biologics appear to be included until exempted and will need to adhere to these requirements as well.