Application Note: How to Respond to (and Avoid) Form 483s

This application note gives a 10 point plan for responding to a Form 483 and features several excerpts from common deviations noted in Form 483s.

Aug 13th, 2013

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

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5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

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PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs

Courses to cover many PDA areas of expertise, including aseptic processing.

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PDA Post-Approval Change Issues and Impacts Survey

This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.

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Serialization Continues to Impact Pharma Automation Investments

Automation and IoT are on trend, as the industry continues to meet serialization regulations.

Govzilla Announces New Customer Platform and Company Name Change to Redica Systems

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Saleable Returns Verification Delayed to 2023

Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.

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Cannabis Policy Vote May Happen by End of 2020

The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.

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Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)

The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.

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CPhI Festival of Pharma 2020 in October

Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.

Smithers tests med devices

Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.

Med Devices and the FDA: Extended Deadline, Worker Safety

In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.

FDA Commissioner Dr. Stephen Hahn

New FDA Insight Podcast on Emerging Topics

First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.

Quick Hits: Allergan is Seeking Women with Recalled Breast Implants

Allergan recalled breast implants more than 10 months ago; now they are trying to find the women who still have them.

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Quick Hits: FDA Gives Emergency Approval to Fitbit’s Ventilator

The wearable tech company developed a new ventilator to help treat the current health crisis.

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States Focus Legislation on Prescription Drug Costs

Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.

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Take PDA's COVID-19 Survey in Pharmaceuticals

The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.

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Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies

The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.

World Health Organization (WHO) declared the Wuhan coronavirus outbreak a global health emergency.

W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads

Most of the 8,000 cases have been reported in mainland China.

Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?

In our column’s continuing effort to correct common misconceptions about packaging law, this month we turn to cannabidiol, or CBD.

More in Regulatory

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Cannabis Packaging: Don't Fear the Reefer

UnPACKed with PMMI Podcast breaks down the latest developments in cannabis packaging as more and more states open the door to legalization.

Controversial new labeling idea

Headlines from the U.K. sound promising but reading deeper reveals very little benefit for contemplating such a major change for food manufacturers.

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FDA Approves Activ-Blister™ Packaging for HIV Drug

The FDA has approved AptarGroup’s packaging solution for oral solid dose HIV prevention medicine.

Holographic foils can be used to great effect to differentiate product at the point-of-sale.

Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy

Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.

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FDA Finds Asbestos in Baby Powder, Recall Ensues

Johnson & Johnson recalled thousands bottles of their famous baby powder after the FDA found trace amounts of asbestos.

Yourway Mitigates Uncertainty of Brexit for Clinical Trials in Europe

Their new location is strategically placed to accommodate both the UK and mainland Europe.

Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain

TraceLink: Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain

The platform is designed to allow users to rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration across the end-to-end life sciences value chain.

Schreiner MediPharm's Flexi-Cap Prime has a combined tear strip for the label and cap

Schreiner MediPharm: Tamper-Evident Flexi-Cap Prime for Vials

The tear strip is designed to ensure that undetected reuse of a container is no longer possible.

Duane Niedert, Director of Operations – Americas for Smithers

Smart Packaging: ‘A Tale of Two Technologies’

A presentation at SmartPack 2019 delves into the current status, forecast, and drivers of the two categories of technology—smart and active—that make up smart packaging.

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FDA Approves New Acute Migraine Drug

Eli Lilly’s new drug Reyvow relieves pain, nausea, and light sensitivity in within two hours of ingestion.

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FDA Approves HIV Drug, But Only for Men

Gilead Sciences only tested Descovy on men and transgender women, and the approval explicitly excludes cisgender women.

Zantac and generic versions of the popular heartburn medicine face concerns about contaminants.

How QR Codes Can Help Drug Makers Streamline Recalls

Concerns about a carcinogenic impurity have prompted recalls of Zantac and generic versions of the popular heartburn medication. Smart labeling technology could speed and clarify alerts to consumers and also help drug companies reduce scrapped lots.