Search Results for Final Rule

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FDA Delays Final Rule on Intended Uses By Michael Mezher - Published 17 March 2017

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

Categories: News, US, FDA, Biologics and biotechnology, Communication, Drugs, Medical Devices

Tags: Intended Use, Final Rule, Totality of Evidence

Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases By Zachary Brennan - Published 17 November 2016

The US Food and Drug Administration (FDA) on Thursday amended its current good manufacturing practice (CGMP) and labeling regulations for medical gases.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: medical gases, FDA final rule

FDA Amends Definition of Custom Device By Zachary Brennan - Published 11 October 2016

The Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Categories: News, US, CDRH, Compliance, Government affairs, Medical Devices, Product withdrawl and retirement, Project management, Quality

Tags: custom medical device, device regulations, premarket notification, FDA final rule

FDA Issues Final Rule on Symbols for Device Labels By Michael Mezher - Published 15 June 2016

The US Food and Drug Administration (FDA) on Wednesday issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards.

Categories: News, US, FDA, In vitro diagnostics, Labeling, Medical Devices

Tags: Final Rule, Symbols

Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US By Zachary Brennan - Published 14 September 2015

As part of its efforts to protect the drug supply chain, the US Food and Drug Administration (FDA) is implementing a final rule that will allow it to destroy a drug valued at $2,500 or less that has been refused entry into the US under federal law.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: final rule, FDA imports, FDA destruction of drugs, drug destruction, illegal drug imports

FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically By Alexander Gaffney, RAC - Published 19 June 2015

The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically.

Categories: News, US, CDRH, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: eMDR, MDR, Adverse Events, 3500A, Final Rule, Medical Device Reporting

FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs Published 22 May 2015

The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Packaging

Tags: FDC, Fixed-Dose Combination, Unified Agenda, Co-Packaged Drugs, Co-Packaged Biologics, Regulation, Proposed Rule, Final Rule

High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy Published 02 February 2015

The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Submission and registration

Tags: AED, Automated External Defibrillator, PMA, 510(k), Regulation, Final Rule

FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard By Alexander Gaffney, RAC - Published 03 December 2014

The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling

Tags: Pregnant, Pregnancy, Nursing, Fetus, Labeling, PLR, Physician Labeling Rule, Pregnancy and Lactation Labeling Rule, PLLR, Draft Guidance, Guidance, Final Rule

DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers By Alexander Gaffney, RAC - Published 21 August 2014

In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.

Categories: News, US, Distribution, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: DEA, Hydrocodone, Schedule II, Schedule III, Final Rule, Rescheduling, Hydrocodone Combination Products

Final Rule Seeks More Stringent Regulation of Tanning Lamps By Alexander Gaffney, RAC - Published 29 May 2014

The US Food and Drug Administration (FDA) has issued a final rule which will regulate ultraviolet lamps used for tanning more stringently, reflecting the lamps' association with skyrocketing rates of skin cancer.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Submission and registration

Tags: CDRH, Sunlamp, UV Lamp, Tanning Bed, Tanning Lamps, Final Rule, Regulation, 510(k), Reclassification

Final Regulation Makes it Easier for FDA to Seize Drugs at the Border By Alexander Gaffney, RAC - Published 28 May 2014

The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded.

Categories: News, US, CBER, CDER, Active pharmaceutical ingredients, Biologics and biotechnology, Distribution, Drugs, Veterinary products

Tags: Detention, import, FDASIA, Adulterated, Misbranded, Destruction, Administrative Detention, Regulation, Final Rule

Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting By Alexander Gaffney, RAC - Published 27 May 2014

The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing, Medical Devices

Tags: US, FDA, Unified Agenda, Proposed Rule, Regulation, Final Rule, 2014 FDA Regulations, DQSA

FDA Down-Classifies Colon, Intravascular Devices By Alexander Gaffney, RAC - Published 15 May 2014

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation.

Categories: News, US, CDRH, Medical Devices

Tags: CDRH, Medical Device, Device Reclassification, Final Rule, Class II, Down-classification

FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted By Alexander Gaffney, RAC - Published 14 March 2014

Categories: US, FDA

Tags: Green Book, Direct Final Rule, Federal Register, NADA, CVM, Transparency, Final Rule, Latest News, regulation

FDA Issues Its Final Rule for Combination Product Quality Systems By Michael Gross, PhD, RAC - Published 19 February 2013

This article provides an explanation of the US Food and Drug Administration's new final rule on Current Good Manufacturing Practice Requirements for Combination Products, which clarifies regulatory requirements for quality systems used to design, develop and manufacture combination products, and helps to ensure consistent and appropriate application and enforcement of these requirements.

Categories: FDA

Tags: Combination Product, Final Rule, regulation

FCC Releases Regulations Governing Medical Body Area Network Devices By Alexander Gaffney - Published 11 September 2012

Tags: Medical Body Area Networks, MBAN, Genachowski, FCC, Final Rule, Latest News, regulation, medical device

FDA Changes Regulation to Allow Some Carcinogenic Products to be Used in Animals By Alexander Gaffney - Published 22 August 2012

Categories: FDA

Tags: DES Proviso, Delaney Clause, Carcinogen, Animal, CVM, Final Rule, Latest News, regulation

In Reversal, FDA to no Longer Publish Agreements in Federal Register By Alexander Gaffney - Published 21 August 2012

Categories: FDA

Tags: Federal Register, MOU, Published, Final Rule, Latest News

UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment' By Alexander Gaffney - Published 26 June 2012

Tags: Adverse Comment, MOU, Withdraw, Final Rule, Latest News, website

New Biologic Sterility Regulation Issued by FDA By Alexander Gaffney - Published 02 May 2012

Categories: FDA

Tags: Contaminants, Sterility Testing, Sterility, Biotechnology, Contamination, Final Rule, Latest News, biologic, regulation, Biologics, regulatory

Revisions to Labeling Requirements for Blood Products Coming in July 2012 By Alexander Gaffney - Published 03 January 2012

Categories: FDA, Blood

Tags: ICCBBA, ISBT, Blood Products, Final Rule, Latest News, Plasma

FDA Issues Interim Rule on Drug Production Discontinuance Published 21 December 2011

Categories: FDA, Regulatory intelligence

Tags: sole manufacturer, manufacturer, production, discontinue, discontinuance, interim final rule