Regulatory Blog

On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode...

On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry. What is...

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...

On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...

USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....

Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s...

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...

US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...